Optical coherence tomography-based ophthalmic testing methods, devices and systems

ABSTRACT

In accordance with one aspect of the present invention, an optical coherence tomography-based ophthalmic testing center system includes an optical coherence tomography instrument comprising an eyepiece for receiving at least one eye of a user or subject; a light source that outputs light that is directed through the eyepiece into the user&#39;s or subject&#39;s eye, an interferometer configured to produce optical interference using light reflected from the user&#39;s/subject&#39;s eye, an optical detector disposed so as to detect said optical interference; and a processing unit coupled to the detector. The ophthalmic testing center system can be configured to perform a multitude of self-administered functional and/or structural ophthalmic tests and output the test data

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 17/249,026, filed on Feb. 17, 2021, which is a is acontinuation of U.S. patent application Ser. No. 16/184,772, now U.S.Pat. No. 10,945,597, filed Nov. 8, 2018, which is a continuation of U.S.patent application Ser. No. 15/349,970, now U.S. Pat. No. 10,165,941,filed Nov. 11, 2016, which is a continuation of U.S. patent applicationSer. No. 14/472,161, now U.S. Pat. No. 9,492,079, filed Aug. 28, 2014,which is a continuation of U.S. patent application Ser. No. 13/054,481,now U.S. Pat. No. 8,820,931, filed May 3, 2011, which is a nationalphase filing of PCT Application No. PCT/US2009/051073, filed Jul. 17,2009, which claims the benefit under 35 U.S.C. 119 to U.S. ProvisionalApplication No. 61/082,171, filed Jul. 18, 2008, U.S. ProvisionalApplication No. 61/082,175, filed Jul. 18, 2008, U.S. ProvisionalApplication No. 61/168,340, filed Apr. 10, 2009, U.S. ProvisionalApplication No. 61/180,837, filed May 23, 2009 U.S. ProvisionalApplication No. 61/221,552, filed Jun. 29, 2009, U.S. ProvisionalApplication No. 61/222,080, filed Jun. 30, 2009. The present applicationis also a continuation-in-part of U.S. patent application Ser. No.15/249,151, filed Aug. 26, 2016, which is a continuation of U.S. patentapplication Ser. No. 14/521,392, filed Oct. 22, 2014, now abandoned,which is a continuation of U.S. patent application Ser. No. 13/717,508,now U.S. Pat. No. 9,149,182, filed on Dec. 17, 2012, which is acontinuation of U.S. patent application Ser. No. 12/111,894, now U.S.Pat. No. 8,348,429, filed on Apr. 29, 2008, which claims prioritybenefit under 35 U.S.C. § 119(e) to U.S. Provisional Application No.61/040,084, filed Mar. 27, 2008. Each of the foregoing applications ishereby incorporated by reference in its entirety, including specificallybut not limited to the systems and method relating to optical coherencetomography-based systems.

BACKGROUND Field

Embodiments of the invention relate to the field of optical coherencetomography and, in particular, to devices, systems, methods of utilizingsuch optical coherence tomography data to perform precision measurementson eye tissue for the detection of eye diseases.

Description of the Related Art

Many industrial, medical, and other applications exist for opticalcoherence tomography (OCT), which generally refers to aninterferometric, non-invasive optical tomographic imaging techniqueoffering millimeter penetration (approximately 2-3 mm in tissue) withmicrometer-scale axial and lateral resolution. For example, in medicalapplications, doctors generally desire a non-invasive, in vivo imagingtechnique for obtaining sub-surface, cross-sectional and/orthree-dimensional images of translucent and/or opaque materials at aresolution equivalent to low-power microscopes. Accordingly, in thecoming years, it is projected that there will be 20 million OCT scansperformed per year on patients. Most of these will probably occur in thefield of ophthalmology. In current optical coherence tomography systems,doctors or other medical professionals administer the OCT scans in thedoctors' medical office or medical facilities.

SUMMARY

Various embodiments of the present invention relate to the utilizationof optical coherence tomography, in conjunction with one or more displaydevices, one or more input devices, and a central processor to perform amultitude of ophthalmic diagnostic tests and other testing in onesingle, small instrument that are currently completed by many separateinstruments. Generally, various embodiments of the optical coherencetomography instruments, devices, systems, and methods disclosed hereincan be self-administered and/or administered with the assistance of alayperson, and the eyepiece can be a binocular system.

In various embodiments, an optical coherence tomography-based systemcomprises an optical coherence tomography device configured to obtain anoptical coherence tomography scan of at least one first anterior eyeregion and at least one of a second intermediate or posterior eyeregion; a processor configured to analyze the optical coherencetomography scan or to generate an optical coherence tomography-basedimage based on the optical coherence tomography scan; and an outputdevice configured to output on the output device a report based on theanalysis of the optical coherence tomography scan or the opticalcoherence tomography-based image.

In various embodiments, an optical coherence tomography-based systemcomprises an optical coherence tomography device configured to obtain anoptical coherence tomography scan of at least one first posterior eyeregion and at least one of a second intermediate or anterior eye region;a processor configured to analyze the optical coherence tomography scanor to generate an optical coherence tomography-based image based on theoptical coherence tomography scan; and an output device configured tooutput on the output device a report based on the analysis of theoptical coherence tomography scan or the optical coherencetomography-based image.

In various embodiments, an optical coherence tomography-basedbiomicroscopy system comprises an optical coherence tomography deviceconfigured to obtain an optical coherence tomography scan alongsubstantially an entire axis of an eye of a subject, said axis extendingbetween at least a corneal structure to at least a retina; a processorconfigured to analyze the optical coherence tomography scan or togenerate an optical coherence tomography-based biomicroscopy image basedon the optical coherence tomography scan; and an output deviceconfigured to output on the output device a report based on the analysisof the optical coherence tomography scan or the optical coherencetomography-based biomicroscopy image.

In various embodiments, an optical coherence tomography-based systemcomprises an optical coherence tomography device configured to obtain afirst optical coherence tomography scan of an eye of a subject, and asecond optical coherence tomography scan of the eye, wherein the firstand second optical coherence tomography scans are arranged along anaxis, the axis extending between an anterior region of the eye to aposterior region of the eye, the first scan being anterior to the secondscan; a processor configured to analyze the first and second opticalcoherence tomography scans or to generate an optical coherencetomography-based image based on the first and second optical coherencetomography scans; and an output device configured to output on theoutput device a report based on the analysis of the first and secondoptical coherence tomography scans or the optical coherencetomography-based image.

In various embodiments, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain an anterior optical coherence tomography scanimaging an anterior region of an eye of a user and to obtain a posterioroptical coherence tomography scan imaging a posterior region of the eyeof the user, the optical coherence tomography device configured toenable the user to self-administer the scan by using the device; aprocessor configured to analyze the anterior and posterior opticalcoherence tomography scans to generate an optical coherencetomography-based image; and an output device configured to output on theoutput device the optical coherence tomography-based image.

In various embodiments, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain an optical coherence tomography scan imaging aregion of a vitreous of an eye of a user, the optical coherencetomography device configured to enable the user to self-administer thescan by using the device; a processor configured to generate an opticalcoherence tomography-based biomicroscopy image of the vitreous based onthe optical coherence tomography scan; and an output device configuredto output on the output device the optical coherence tomography-basedimage of the vitreous.

In various embodiments, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain a first optical coherence tomography scan of aregion of an eye of a user at a first time period and a second opticalcoherence tomography scan of the region of the eye of the user at asecond time period; a processor configured to perform movement trackingof at least one structural element of the eye between the first andsecond optical coherence tomography scans, and the processor configuredto perform at least one of an ophthalmic functional test based on themovement tracking or a structural test; and an output device configuredto generate an output on the output device based on the at least oneophthalmic functional test or the structural test.

In various embodiments, an ophthalmic testing system comprises animaging device configured to obtain a first image of a region of an eyeof a subject at a first time period and a second image of the region ofthe eye of the subject at a second time period; a processor configuredto perform movement tracking of at least one structural element of theeye between the first and second images, and the processor configured toperform at least one ophthalmic functional test based on the movementtracking; and an output device configured to generate an output on theoutput device based on the at least one ophthalmic functional test.

In various embodiments, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain an optical coherence tomography scan of a region ofan eye; a processor configured to conduct a binocular extraocularmotility test on the eye based on the optical coherence tomography scan;and an output device configured to generate an output on the outputdevice based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain an optical coherence tomography scan of a region ofan eye; a processor configured to conduct a pupillometry test on the eyebased on the optical coherence tomography scan; and an output deviceconfigured to generate an output on the output device based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain an optical coherence tomography scan of a region ofan eye; a processor configured to conduct an exophthalmometry test onthe eye based on the optical coherence tomography scan; and an outputdevice configured to generate an output on the output device based onthe test.

In various embodiments, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain an optical coherence tomography scan of a region ofan eye; a processor configured to conduct a foveal suppression test onthe eye based on the optical coherence tomography scan; and an outputdevice configured to generate an output on the output device based onthe test.

In various embodiments, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain an optical coherence tomography scan of a region ofan eye; a processor configured to conduct a stereoacuity test on the eyebased on the optical coherence tomography scan; and an output deviceconfigured to generate an output on the output device based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain an optical coherence tomography scan of a region ofan eye; a processor configured to conduct an ocular alignment test onthe eye based on the optical coherence tomography scan; and an outputdevice configured to generate an output on the output device based onthe test.

In various embodiments, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain an optical coherence tomography scan of a region ofan eye; a processor configured to conduct a visual acuity test on theeye based on the optical coherence tomography scan; and an output deviceconfigured to generate an output on the output device based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain an optical coherence tomography scan of a region ofan eye; a processor configured to conduct a static perimetry test on theeye based on the optical coherence tomography scan; and an output deviceconfigured to generate an output on the output device based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain an optical coherence tomography scan of a region ofan eye; a processor configured to conduct a kinetic perimetry test onthe eye based on the optical coherence tomography scan; and an outputdevice configured to generate an output on the output device based onthe test.

In various embodiments, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain an optical coherence tomography scan of a region ofan eye; a processor configured to conduct a refractive error measurementon the eye based on the optical coherence tomography scan; and an outputdevice configured to generate an output on the output device based onthe test.

In various embodiments, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain an optical coherence tomography scan of a region ofan eye; a processor configured to conduct an ocular motility test on theeye based on the optical coherence tomography scan; and an output deviceconfigured to generate an output on the output device based on the test.

In various embodiment, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain an optical coherence tomography scan of a region ofan eye; a processor configured to conduct a contrast sensitivity test onthe eye based on the optical coherence tomography scan; and an outputdevice configured to generate an output on the output device based onthe test.

In various embodiments, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain an optical coherence tomography scan of a region ofan eye; a processor configured to conduct a color vision test on the eyebased on the optical coherence tomography scan; and an output deviceconfigured to generate an output on the output device based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain an optical coherence tomography scan of a region ofan eye; a processor configured to conduct a central visual distortiontest on the eye based on the optical coherence tomography scan; and anoutput device configured to generate an output on the output devicebased on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain an optical coherence tomography scan of a region ofan eye; a processor configured to conduct a reading speed test on theeye based on the optical coherence tomography scan; and an output deviceconfigured to generate an output on the output device based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain an optical coherence tomography scan of a region ofan eye of a user, wherein the optical coherence tomography device isconfigured to enable the user to self-administer the scan by using thedevice; a processor configured to conduct a corneal topography test onthe eye based on the optical coherence tomography scan; and an outputdevice configured to generate an output on the output device based onthe test.

In various embodiments, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain an optical coherence tomography scan of a region ofan eye of a user, wherein the optical coherence tomography device isconfigured to enable the user to self-administer the scan by using thedevice; a processor configured to conduct a corneal pachymetry test onthe eye based on the optical coherence tomography scan; and an outputdevice configured to generate an output on the output device based onthe test.

In various embodiments, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain an optical coherence tomography scan of a region ofan eye of a user, wherein the optical coherence tomography device isconfigured to enable the user to self-administer the scan by using thedevice; a processor configured to conduct a gonioscopy test on the eyebased on the optical coherence tomography scan; and an output deviceconfigured to generate an output on the output device based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting system comprises an optical coherence tomography deviceconfigured to obtain an anterior optical coherence tomography scan of aanterior region of an eye of a subject, and to obtain a posterioroptical coherence tomography scan of a posterior region of the eye, andto obtain an intermediate optical coherence tomography scan of a regionin between the anterior region and posterior region of the eye; aprocessor configured to analyze the anterior, posterior, andintermediate optical coherence tomography scans or to the generate anoptical coherence tomography-based image based on the optical coherencetomography scans; and an output device configured to generate an outputon the output device a report based on the analysis or the opticalcoherence tomography-based image.

In various embodiments, an optical coherence tomography-based ophthalmictesting system for conducting a best fixating retina verificationcomprises an optical coherence tomography device configured to identifya region for a best fixating retina detection, and the optical coherencetomography device configured to generate a scan of the region; aprocessor configured to analyze the optical coherence tomography scan todetermine the presence of a fovea; and an output device configured togenerate an output on the output device based on the analysis.

In various embodiments, an optical coherence tomography-based ophthalmictesting system for conducting a best fixating retina search comprises anoptical coherence tomography device configured to generate athree-dimensional optical coherence tomography scan of a region; aprocessor configured to analyze the three-dimensional optical coherencetomography scan to determine the location of a best fixating retina; andan output device configured to generate an output on the output devicebased on the analysis.

In various embodiments, an optical coherence tomography-basedbiomicroscopy system comprises an optical coherence tomography deviceconfigured perform coherence tomography scans; a processor configured toobtain a first set of optical coherence tomography data from a firstoptical coherence tomography scan and a set of second optical coherencetomography data from said first optical coherence tomography scan orfrom a second optical coherence tomography scan, said processor furtherconfigured to logically operate on the first set of optical coherencetomography data with the second set of optical coherence tomography datato produce a resultant optical coherence tomography scan with less ghostimagery than said first optical coherence tomography scan; and an outputdevice configured to generate an output on the output device based onthe resultant scan.

In various embodiments, an optical coherence tomography-based methodcomprises obtaining an optical coherence tomography scan, using anoptical coherence tomography device, of at least one first anterior eyeregion and at least one of a second intermediate or posterior eyeregion; using a processor to analyze the optical coherence tomographyscan or to generate an optical coherence tomography-based image based onthe optical coherence tomography scan; and outputting on an outputdevice a report based on the analysis of the optical coherencetomography scan or the optical coherence tomography-based image.

In various embodiments, an optical coherence tomography-based methodcomprises obtaining an optical coherence tomography scan, using anoptical coherence tomography device, of at least one first posterior eyeregion and at least one of a second intermediate or anterior eye region;using a processor to analyze the optical coherence tomography scan or togenerate an optical coherence tomography-based image based on theoptical coherence tomography scan; and outputting on an output device areport based on the analysis of the optical coherence tomography scan orthe optical coherence tomography-based image.

In various embodiments, an optical coherence tomography-basedbiomicroscopy method comprises obtaining an optical coherence tomographyscan, using an optical coherence tomography device, along substantiallyan entire axis of an eye of a subject, said axis extending between atleast a corneal structure to at least a retina; using a processor toanalyze the optical coherence tomography scan or to generate an opticalcoherence tomography-based biomicroscopy image based on the opticalcoherence tomography scan; and outputting on an output device a reportbased on the analysis of the optical coherence tomography scan or theoptical coherence tomography-based biomicroscopy image.

In various embodiments, an optical coherence tomography-based methodcomprises obtaining, using an optical coherence tomography device, afirst optical coherence tomography scan of an eye of a subject, and asecond optical coherence tomography scan of the eye, wherein the firstand second optical coherence tomography scans are arranged along anaxis, the axis extending between an anterior region of the eye to aposterior region of the eye, the first scan being anterior to the secondscan; using a processor to analyze the first and second opticalcoherence tomography scans or to generate an optical coherencetomography-based image based on the first and second optical coherencetomography scans; and outputting on an output device a report based onthe analysis of the first and second optical coherence tomography scansor the optical coherence tomography-based image.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, an anterior optical coherence tomography scan imagingan anterior region of an eye of a user and to obtain a posterior opticalcoherence tomography scan imaging a posterior region of the eye of theuser, wherein the user self-administers the scan by using the device;using a processor to analyze the anterior and posterior opticalcoherence tomography scans to generate an optical coherencetomography-based image; and outputting on an output device the opticalcoherence tomography-based image.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, an optical coherence tomography scan imaging a regionof a vitreous of an eye of a user, the optical coherence tomographydevice configured to enable the user to self-administer the scan byusing the device; using a processor to generate an optical coherencetomography-based image of the vitreous based on the optical coherencetomography scan; and outputting on an output device the opticalcoherence tomography-based image of the vitreous.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, a first optical coherence tomography scan of a regionof an eye of a user at a first time period and a second opticalcoherence tomography scan of the region of the eye of the user at asecond time period; using a processor to perform movement tracking of atleast one structural element of the eye between the first and secondoptical coherence tomography scans, and to perform at least one of anophthalmic functional test based on the movement tracking or astructural test; and outputting on an output device an output based onthe at least one ophthalmic functional test or the structural test.

In various embodiments, an ophthalmic testing method comprisesobtaining, using an imaging device, a first image of a region of an eyeof a subject at a first time period and a second image of the region ofthe eye of the subject at a second time period; using a processor toperform movement tracking of at least one structural element of the eyebetween the first and second images, and to perform at least oneophthalmic functional test based on the movement tracking; andoutputting on an output device an output based on the at least oneophthalmic functional test.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, an optical coherence tomography scan of a region ofan eye; using a processor to conduct a binocular extraocular motilitytest on the eye based on the optical coherence tomography scan; andoutputting on an output device an output based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, an optical coherence tomography scan of a region ofan eye; using a processor to conduct a pupillometry test on the eyebased on the optical coherence tomography scan; and outputting on anoutput device an output based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, an optical coherence tomography scan of a region ofan eye; using a processor to conduct an exophthalmometry test on the eyebased on the optical coherence tomography scan; and outputting on anoutput device an output based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, an optical coherence tomography scan of a region ofan eye; using a processor to conduct a foveal suppression test on theeye based on the optical coherence tomography scan; and outputting on anoutput device an output based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, an optical coherence tomography scan of a region ofan eye; using a processor to conduct a stereoacuity test on the eyebased on the optical coherence tomography scan; and outputting on anoutput device an output based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, an optical coherence tomography scan of a region ofan eye; using a processor to conduct an ocular alignment test on the eyebased on the optical coherence tomography scan; and outputting on anoutput device an output based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, an optical coherence tomography scan of a region ofan eye; using a processor to conduct a visual acuity test on the eyebased on the optical coherence tomography scan; and outputting on anoutput device an output based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, an optical coherence tomography scan of a region ofan eye; using a processor to conduct a static perimetry test on the eyebased on the optical coherence tomography scan; and outputting on anoutput device an output based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, an optical coherence tomography scan of a region ofan eye; using a processor to conduct a kinetic perimetry test on the eyebased on the optical coherence tomography scan; and outputting on anoutput device an output based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, an optical coherence tomography scan of a region ofan eye; using a processor to conduct a refractive error measurement onthe eye based on the optical coherence tomography scan; and outputtingon an output device an output based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, an optical coherence tomography scan of a region ofan eye; using a processor to conduct an ocular motility test on the eyebased on the optical coherence tomography scan; and outputting on anoutput device an output based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, an optical coherence tomography scan of a region ofan eye; using a processor to conduct a contrast sensitivity test on theeye based on the optical coherence tomography scan; and outputting on anoutput device an output based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, an optical coherence tomography scan of a region ofan eye; using a processor to conduct a color vision test on the eyebased on the optical coherence tomography scan; and outputting on anoutput device an output based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, an optical coherence tomography scan of a region ofan eye; using a processor to conduct a central visual distortion test onthe eye based on the optical coherence tomography scan; and outputtingon an output device an output based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, an optical coherence tomography scan of a region ofan eye; using a processor to conduct a reading speed test on the eyebased on the optical coherence tomography scan; and outputting on anoutput device an output based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, an optical coherence tomography scan of a region ofan eye of a user, wherein the optical coherence tomography device isconfigured to enable the user to self-administer the scan by using thedevice; using a processor to conduct a corneal topography test on theeye based on the optical coherence tomography scan; and outputting on anoutput device an output based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, an optical coherence tomography scan of a region ofan eye of a user, wherein the optical coherence tomography device isconfigured to enable the user to self-administer the scan by using thedevice; using a processor to conduct a corneal pachymetry test on theeye based on the optical coherence tomography scan; and outputting on anoutput device an output based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, an optical coherence tomography scan of a region ofan eye of a user, wherein the optical coherence tomography device isconfigured to enable the user to self-administer the scan by using thedevice; using a processor to conduct a gonioscopy test on the eye basedon the optical coherence tomography scan; and outputting on an outputdevice an output based on the test.

In various embodiments, an optical coherence tomography-based ophthalmictesting method comprises obtaining, using an optical coherencetomography device, an anterior optical coherence tomography scan of aanterior region of an eye of a subject, and a posterior opticalcoherence tomography scan of a posterior region of the eye, and anintermediate optical coherence tomography scan of a region in betweenthe anterior region and posterior region of the eye; using a processorto analyze the anterior, posterior, and intermediate optical coherencetomography scans or to the generate an optical coherencetomography-based image based on the optical coherence tomography scans;and outputting on an output device a report based on the analysis or theoptical coherence tomography-based image.

In various embodiments, an optical coherence tomography-based ophthalmictesting method for conducting a best fixating retina verificationcomprises identifying, using an optical coherence tomography device, aregion for a best fixating retina detection; generating, using theoptical coherence tomography device, a scan of the region; using aprocessor to analyze the optical coherence tomography scan to determinethe presence of a fovea; and outputting on an output device an outputbased on the analysis.

In various embodiments, an optical coherence tomography-based ophthalmictesting method for conducting a best fixating retina search comprisesgenerating, using an optical coherence tomography device, athree-dimensional optical coherence tomography scan of a region; using aprocessor to analyze the three-dimensional optical coherence tomographyscan to determine the location of a best fixating retina; and outputtingon an output device an output based on the analysis.

In various embodiments, an optical coherence tomography-basedbiomicroscopy method comprises performing, using an optical coherencetomography device, optical coherence tomography scans; using a processorto obtain a first set of optical coherence tomography data from a firstoptical coherence tomography scan and a set of second optical coherencetomography data from said first optical coherence tomography scan orfrom a second optical coherence tomography scan, further using saidprocessor to logically operate on the first set of optical coherencetomography data with the second set of optical coherence tomography datato produce a resultant optical coherence tomography scan with less ghostimagery than said first optical coherence tomography scan; andoutputting on an output device an output based on the resultant scan.

In an embodiment, a chronic eye disease optical coherence tomographymeasuring and monitoring system comprises an optical coherencetomography measurement device for measuring at least one ophthalmiccharacteristic of at least one eye of a user. The optical coherencetomography measurement can be configured to enable the user toself-administer the measuring by using the optical coherence tomographymeasurement device. The optical coherence tomography measuring andmonitoring system also comprises a processor configured to compare themeasured optical coherence tomography characteristic with at least onepreviously measured optical coherence tomography characteristic of theuser stored in a storage medium. The processor can further be configuredto determine a difference between the measured optical coherencetomography characteristic and the previously measured optical coherencetomography characteristic. The processor can also be configured todetermine that an increased probability exists for required treatment ifthe difference satisfies the at least one criterion. The opticalcoherence tomography measuring and monitoring system further comprisesan output device for generating an output to the user, the processorfurther configured to generate an output on the output device based onthe difference.

In an embodiment, a method for self-administering an optical coherencetomography test to monitor an ophthalmic condition comprises receivinginformation related to the ophthalmic condition, obtaining opticalcoherence tomography measurements of at least one user eye using anoptical coherence tomography instrument, determining an ophthalmicoutput based on results of the optical coherence tomography scanning,the output being related to a state of the ophthalmic condition, andoutputting the ophthalmic condition to at least one of the user, ahealthcare provider and an agent of the healthcare provider.

In an embodiment, an optical coherence tomography system comprises aninput device configured to receive information related to an ophthalmiccondition, an eyepiece for receiving at least one eye of a user, a lightsource that outputs light that is directed through the eyepiece into theuser's eye, an interferometer configured to produce optical interferenceusing light reflected from the user's eye, an optical detector disposedso as to detect said optical interference, electronics coupled to thedetector and configured to analyze optical coherence tomographymeasurements obtained using said interferometer and determine anophthalmic output related to a state of the ophthalmic condition, and anoutput device electrically coupled to the electronics, the output deviceconfigured to output the ophthalmic output.

In an embodiment, a self-administered optical coherence tomographysystem for glaucoma detection comprises an optical coherence tomographymeasurement device configured to obtain a first set of optical coherencetomography data for a first region of an eye of a user and a second setof optical coherence tomography data for a second region of the eye. Thefirst and second regions of the eyes can be at differentanterior-posterior depths. The optical coherence tomography measurementdevice can also be configured to enable the user to self-administer thescanning by using the device. The self-administered optical coherencetomography system for glaucoma detection also comprises a processorconfigured to determine a first boundary position using the first set ofoptical coherence tomography data and to determine a second boundaryposition using the second set of optical coherence tomography data. Theprocessor can further be configured to determine an ophthalmic distancebased on the first boundary position and the second boundary positionand to compare the ophthalmic distance with a threshold value to screenfor glaucoma in the eye. The self-administered optical coherencetomography system for glaucoma detection further comprises an outputdevice configured to generate an output on the output device based onthe comparison.

In an embodiment, a glaucoma detection method for providing aself-administered optical coherence tomography test of a user's eyecomprises obtaining optical coherence tomography measurements of ananterior segment at least one user eye using an optical coherencetomography instrument, determining an ophthalmic output based on resultsof the optical coherence tomography scanning, the output being relatedto a state of glaucoma, and outputting the ophthalmic output to at leastone of the user, a healthcare provider and an agent of the healthcareprovider.

In various embodiments, an optical coherence tomography instrument fordetecting the causes of amblyopia comprises an eyepiece for receivingboth eyes of a subject; a light source that outputs light that isdirected through the eyepiece into the subject's eyes; an interferometerconfigured to produce optical interference using light reflected fromthe subject's eyes; an optical detector disposed so as to detect saidoptical interference in the subject's eyes; a processing module coupledto the detector and configured to perform an analysis to automaticallydetect the causes of amblyopia based on optical coherence tomographymeasurements obtained using said interferometer; and an output deviceelectrically coupled to the processing module, said output deviceconfigured to output results of the amblyopia analysis to the subjectthrough the output device.

In various embodiments, an optical coherence tomography instrument fordetecting strabismus comprises an eyepiece for receiving both eyes of asubject; a light source that outputs light that is directed through theeyepiece into the subject's eyes; an interferometer configured toproduce optical interference using light reflected from the subject'seyes; an optical detector disposed so as to detect said opticalinterference in the subject's eyes; a processing module coupled to thedetector and configured to perform an analysis to automatically detectstrabismus based on optical coherence tomography measurements obtainedusing said interferometer; and an output device electrically coupled tothe processing module, said output device configured to output resultsof the strabismus analysis to the subject through the output device.

In various embodiments, an optical coherence tomography instrument fordetecting refractive error disorders comprises an eyepiece for receivingboth eyes of a subject; a light source that outputs light that isdirected through the eyepiece into the subject's eyes; an interferometerconfigured to produce optical interference using light reflected fromthe subject's eyes; an optical detector disposed so as to detect saidoptical interference in the subject's eyes; a processing module coupledto the detector and configured to perform an analysis to automaticallydetect refractive error disorders based on optical coherence tomographymeasurements obtained using said interferometer; and an output deviceelectrically coupled to the processing module, said output deviceconfigured to output results of the refractive error disorders analysisto the subject through the output device.

In various embodiments, an optical coherence tomography instrument fordetecting eye occlusion comprises an eyepiece for receiving both eyes ofa subject; a light source that outputs light that is directed throughthe eyepiece into the subject's eyes; an interferometer configured toproduce optical interference using light reflected from the subject'seyes; an optical detector disposed so as to detect said opticalinterference in the subject's eyes; a processing module coupled to thedetector and configured to perform an analysis to automatically detecteye occlusion based on optical coherence tomography measurementsobtained using said interferometer; and an output device electricallycoupled to the processing module, said output device configured tooutput results of the eye occlusion analysis to the subject through theoutput device.

In various embodiments, an interpupillary distance measurement devicecomprises an ocular eyepiece comprising at least two openings, theopenings configured for placement on eyes of a subject; and a supportstructure having a measurement guide, the support structure connected tothe ocular eyepiece, the support configured to be adjustable forallowing the two openings to be slidable with respect to each other andto measure the interpupillary distance of the subject, the measurementguide configured to change in dimension based on the measuredinterpupillary distance; wherein the measurement guide is configured tobe connected to an OCT instrument to be adjusted to the measuredinterpupillary distance of the subject.

In various embodiments, an optical coherence tomography instrument formeasuring dioptric power of eyes of a subject, the instrument comprisesan eyepiece for receiving both eyes of a subject; a light source thatoutputs light that is directed through the eyepiece into the eyes of thesubject; an interferometer configured to produce optical interferenceusing light reflected from the eyes of the subject; an optical detectordisposed so as to detect said optical interference in the eyes of thesubject; a processing module coupled to the detector and configured toperform an analysis to automatically measure dioptric power based onoptical coherence tomography measurements obtained using saidinterferometer; an output device electrically coupled to the processingmodule, said output device configured to output results of the dioptricpower analysis to the subject through the output device; and anauto-focus system for automatically determining refractive errors foreach eye of the subject, wherein the processing module is configured toperform the refractive error analysis based on optical coherencetomography measurements and focus measurements obtained using thebilateral auto-focus system.

In various embodiments, a computer-implemented method for detecting thecauses of amblyopia, the computer-implemented method comprises receivingthe eyes of a subject in an eyepiece; outputting light from a lightsource that is directed through the eyepiece into the subject's eyes;producing optical interference using an interferometer and the lightreflected from the subject's eyes; detecting said optical interferencein the subject's eyes using an optical detector; performing an analysis,using a processing module coupled to the detector, to automaticallydetect the causes of amblyopia based on optical coherence tomographymeasurements obtained using said interferometer; and generating anoutput through an output device electrically coupled to the processingmodule, the output comprising the results of the amblyopia analysis.

In various embodiments, an optical coherence tomography instrument forestimating visual acuity of a subject, the optical coherence tomographyinstrument comprises an eyepiece for receiving both eyes of a subject; alight source that outputs light that is directed through the eyepieceinto the subject's eyes; an interferometer configured to produce opticalinterference using light reflected from the subject's eyes; an opticaldetector disposed so as to detect said optical interference in thesubject's eyes; a processing module coupled to the detector andconfigured to perform an analysis to automatically estimate visualacuity based on data measurements obtained using said light source; andan output device electrically coupled to the processing module, saidoutput device configured to output results of the visual acuity analysisto the subject through the output device.

In various embodiments, the optical tomography instrument of claim 51,further comprises a fixation marker control module configured to changethe fixation mark shown to the eyes of the subject; the processingcontrol module further configured to generate a plurality of B-scansbased on optical coherence tomography measurements obtained at differenttimes and changes in the fixation mark, wherein the processing controlmodule is further configured to automatically detect changes in theplurality of B-scans; wherein the processing control module is furtherconfigured to output through the output device that a visual acuitydisorder has been detected if the detected change in the plurality ofB-scans is greater than a threshold value.

In various embodiments, an optical coherence tomography instrument forestimating optic nerve head volume to monitor glaucoma in a subject, theoptical coherence tomography instrument comprises an eyepiece forreceiving both eyes of a subject; a light source that outputs light thatis directed through the eyepiece into the subject's eyes; aninterferometer configured to produce optical interference using lightreflected from the subject's eyes; an optical detector disposed so as todetect said optical interference in the subject's eyes; a processingmodule coupled to the detector and configured to perform an analysis toautomatically estimate optic nerve head volume in both eyes based onoptical coherence tomography measurements obtained using saidinterferometer; and an output device electrically coupled to theprocessing module, said output device configured to output results ofthe optic nerve head volume analysis to the subject through the outputdevice.

In various embodiments, an optical coherence tomography instrument forestimating the angular misalignment between two eyes for determiningprism lens prescriptions in a subject, the optical coherence tomographyinstrument comprises an eyepiece for receiving both eyes of a subject; alight source that outputs light that is directed through the eyepieceinto the subject's eyes; an interferometer configured to produce opticalinterference using light reflected from the subject's eyes; an opticaldetector disposed so as to detect said optical interference in thesubject's eyes; a processing module coupled to the detector andconfigured to perform an analysis to automatically estimate the angularmisalignment between two eyes based on optical coherence tomographymeasurements obtained using said interferometer; and an output deviceelectrically coupled to the processing module, said output deviceconfigured to output results of the angular misalignment analysis reportthrough the output device.

For purposes of this summary, certain aspects, advantages, and novelfeatures of the invention are described herein. It is to be understoodthat not necessarily all such aspects, advantages, and features may beemployed and/or achieved in accordance with any particular embodiment ofthe invention. Thus, for example, those skilled in the art willrecognize that the invention may be embodied or carried out in a mannerthat achieves one advantage or group of advantages as taught hereinwithout necessarily achieving other advantages as may be taught orsuggested herein.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features, aspects and advantages of the presentinvention are described in detail below with reference to the drawingsof various embodiments, which are intended to illustrate and not tolimit the invention. The drawings comprise the following figures inwhich:

FIG. 1 is a schematic diagram of one embodiment of the optical coherencetomography system described herein.

FIG. 2 is a schematic diagram of one embodiment of an interferometerarranged to perform measurements of an eye.

FIG. 3A is a schematic diagram of one embodiment of an OCT systemcomprising a main body configured to conveniently interfere with aperson's eyes, the main body being in communication with various systemsas described herein.

FIG. 3B is a perspective view schematically illustrating an embodimentof the main body shown in FIG. 3A.

FIG. 4 is schematic diagram of one embodiment of a spectrometer used toanalyze data from an interferometer used for OCT.

FIG. 5 is a schematic diagram of the main body of an OCT systemcomprising a single display for presenting a display target to apatient/subject.

FIGS. 6A-6C are schematic diagrams illustrating the use of opticalcoherence tomography to scan retinal tissue to generate A-scans andB-scans.

FIGS. 7A-7F are schematic diagrams illustrating embodiments foradjusting and/or calibrating interpupillary distance.

FIG. 8 is a block diagram schematically illustrating one embodiment ofthe computer system of the optical coherence tomography system describedherein.

FIG. 9 is illustrates a process flow diagram of one embodiment ofperforming precision measurements on retinal tissue for the detection ofpathognomonic disease features.

FIGS. 10A-10D illustrate possible embodiments of disposing the main bodyof an optical coherence tomography device with respect to a user.

FIGS. 11A-11B illustrate possible embodiments of output reportsgenerated by the optical coherence tomography device.

FIG. 12 is a block diagram schematically illustrating another embodimentof the computer system for an optical coherence tomography systemdescribed herein.

FIG. 13 is a block diagram schematically illustrating components in oneembodiment of the computer system for an optical coherence tomographysystem described herein.

FIG. 14A is a diagram schematically illustrating one embodiment fordetermining a risk assessment.

FIG. 14B is a schematic illustration of a plot of risk of retinaldisease versus retinal thickness for determining a risk assessment inanother embodiment.

FIG. 15 is an illustration of RPE detection and RPE polynomial fitcurvature, and the difference there between.

FIG. 16 is an illustration of retinal tissue segmented into inner andouter retinal tissue regions.

FIGS. 17A-C show B-scans obtained when the OCT system is positioned toofar anterior, at a position that provides increased field of view, ortoo far posterior with respect to the eye.

FIGS. 18A-C show light beam trajectories when the OCT system ispositioned too far anterior, at a position that provides increased fieldof view, or too far posterior wherein the intersection of thetrajectories is behind the pupil, at a pupil plane or in front of thepupil.

FIG. 19 shows one embodiment of a suitable working distance between anoptical coherence tomography system and a retina of a subject/patient.

FIG. 20 shows a process for monitoring an ophthalmic condition using anoptical coherence tomography system.

FIG. 21 is a block diagram of one embodiment of an OCT system comprisingan input device and an output device that can be used to monitor anophthalmic condition.

FIG. 22 is high-level flow diagram illustrating an example of using aninterpupillary distance measurement device, for example on anuncooperative or pediatric subject, to determine the appropriateinterpupillary distance for a binocular OCT system.

FIG. 23 is high-level flow diagram illustrating an example process forusing an OCT system to detect causes of amblyopia such as strabismus,anisometropia, isoametropia, visual occlusion, and the like.

FIG. 24 is a high-level flow diagram illustrating an example process forusing an OCT system to estimate the corrected or uncorrected refractiveerror of an eye in diopters.

FIG. 25 comprises example illustrations of OCT system-generated imagesof retinas, and the images can be used to detect causes of amblyopia, orstrabismus, anisometropia, isoametropia, visual occlusion, and the like.

FIG. 26 is a high-level block diagram schematically illustratingcomponents in one embodiment of the computer system for the opticalcoherence tomography systems described herein.

FIG. 27 is a high-level eye anatomy diagram, illustrating an embodimentfor estimating angular misalignment between two eyes.

FIG. 28 is a block diagram schematically illustrating one embodiment ofan optical coherence tomography-based ophthalmic testing center systemdescribed herein.

FIG. 29 is a diagram illustrating a generic freestanding embodiment ofan OCT device.

FIGS. 30A-30F illustrate various embodiments of OCT devices of anOCT-based ophthalmic testing center system.

FIG. 31 illustrates an embodiment of performing refractive errorcorrection on an emmetropic eye.

FIGS. 32A and 32B illustrate an embodiment of performing refractiveerror correction on a myopic eye.

FIGS. 33A and 33B illustrate an embodiment of performing refractiveerror correction on a hyperopic eye.

FIGS. 34A and 34B illustrate an embodiment of performing refractiveerror correction on a presbyopic eye.

FIGS. 35A, 35B, 35C, 36, and 37 illustrate various embodiments ofperforming eye tracking functions using the OCT-based ophthalmic testingcenter system as described herein.

FIG. 38 illustrates various embodiments of performing OCT biomicroscopytests using the OCT-based ophthalmic testing center system as describedherein.

FIG. 39 illustrates an embodiment of an extraocular motility testconducted using the OCT-based ophthalmic testing center system asdescribed herein.

FIG. 40 illustrates an embodiment of a pupillometry test conducted usingthe OCT-based ophthalmic testing center system as described herein.

FIG. 41 illustrates an embodiment of an exophthalmometry test conductedusing the OCT-based ophthalmic testing center system as describedherein.

FIG. 42 illustrates various embodiments of visual acuity tests conductedusing the OCT-based ophthalmic testing center system as describedherein.

FIG. 43 illustrates an embodiment of a contrast sensitivity testconducted using the OCT-based ophthalmic testing center system asdescribed herein and an embodiment of a graph illustrating output fromthe contrast sensitivity test.

FIG. 44 illustrates various embodiments of output generated byperforming fixation stability tests using the OCT-based ophthalmictesting center system as described herein.

FIG. 45 illustrates an embodiment of a confrontation visual fieldperimetry test conducted using the OCT-based ophthalmic testing centersystem as described herein.

FIG. 46 illustrates an embodiment of a kinetic perimetry test conductedusing the OCT-based ophthalmic testing center system as describedherein.

FIG. 47 illustrates an embodiment of a static perimetry test conductedusing the OCT-based ophthalmic testing center system as describedherein.

FIG. 48 illustrates various embodiments of a corneal topography testconducted using the OCT-based ophthalmic testing center system asdescribed herein.

FIG. 49 illustrates an embodiment of a corneal pachymetry test conductedusing the OCT-based ophthalmic testing center system as describedherein.

FIG. 50 illustrates an embodiment of a virtual gonioscopy test conductedusing the OCT-based ophthalmic testing center system as describedherein.

FIG. 51 illustrates various embodiments of measurements generated by avirtual gonioscopy test conducted using the OCT-based ophthalmic testingcenter system as described herein.

FIG. 52A-52C illustrates various embodiments of a color vision testconducted using the OCT-based ophthalmic testing center system asdescribed herein.

FIG. 53 illustrates various embodiments of a vision distortion testconducted using the OCT-based ophthalmic testing center system asdescribed herein.

FIG. 54 illustrates an embodiment of a reading speed test conductedusing the OCT-based ophthalmic testing center system as describedherein.

FIGS. 55 and 56 illustrate an embodiment of a stereoacuity testconducted using the OCT-based ophthalmic testing center system asdescribed herein.

FIGS. 57 and 58 illustrate various embodiments of a foveal suppressiontest conducted using the OCT-based ophthalmic testing center system asdescribed herein.

FIG. 59 is a schematic diagram of one embodiment of an OCT device asdescribed herein.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Embodiments of the invention will now be described with reference to theaccompanying figures, wherein like numerals refer to like elementsthroughout. The terminology used in the description presented herein isnot intended to be interpreted in any limited or restrictive manner,simply because it is being utilized in conjunction with a detaileddescription of certain specific embodiments of the invention.Furthermore, embodiments of the invention may comprise several novelfeatures, no single one of which is solely responsible for its desirableattributes or which is essential to practicing the inventions hereindescribed. The embodiments described herein make OCT screening moreaccessible to users thereby allowing for earlier detection and/ortreatment of various diseases, ailments, or conditions, for example,maculopathy, glaucoma, or the like.

The terms “optical coherence tomography” and “OCT” generally refer to aninterferometric technique for imaging samples, in some cases, withmicrometer lateral resolution. This non-invasive optical tomographicimaging technique is used in ophthalmology to provide cross-sectionalimages of the eye, and more particularly the posterior of the eye,though it can also be used to image other samples or tissues in areas ofthe user's body.

Generally, OCT employs an interferometer. Light from a light source (forexample, a broadband light source, swept source, or tunable laser) issplit (for example, by a beam splitter) and travels along a sample arm(generally comprising the sample) and a reference arm (generallycomprising a mirror). Alternatively, the light from the light source cantravel down fiber optics, microfiber, and/or any other medium capable oftransmitting light. A portion of the light from the sample arm isreflected by the sample. Light is also reflected from a mirror in thereference arm. (Light from the test arm and the reference arm isrecombined, for example by the beam splitter.) When the distancetravelled by light in the sample arm is within a coherence length of thedistance travelled by light in the reference arm, optical interferenceoccurs, which affects the intensity of the recombined light. Theintensity of the combined reflected light varies depending on the sampleproperties. Thus, variations for the intensity of the reflectancemeasured are indications of the physical features of the sample beingtested.

In time-domain OCT, the length of the reference arm can be varied (forexample, by moving one or more reference mirrors). The reflectanceobserved as the reference arm distance changes indicates sampleproperties at different depths of the sample. (In some embodiments, thelength of the sample arm is varied instead of or in addition to thevariation of the reference arm length.) In frequency-domain OCT, thedistance of the reference arm can be fixed, and the reflectance can thenbe measured at different frequencies. For example, the frequency oflight emitted from a light source can be scanned across a range offrequencies or a dispersive element, such as a grating, and a detectorarray may be used to separate and detect different wavelengths. Fourieranalysis can convert the frequency-dependent reflectance properties todistance-dependent reflectance properties, thereby indicating sampleproperties at different sample depths. In certain embodiments, OCT canshow additional information or data other than nonmydriatic color fundusimaging.

The term “A-scan” describes the light reflectivity associated withdifferent sample depths. The term “B-scan” as used herein refers to theuse of cross-sectional views of tissues formed by assembly of aplurality of A-scans. In the case of ophthalmology, light reflected byeye tissues is converted into electrical signals and can be used toprovide data regarding the structure of tissue in the eye and to displaya cross-sectional view of the eye. In the case of ophthalmology, A-scansand B-scans can be used, for example, for differentiating normal andabnormal eye tissue or for measuring thicknesses of tissue layers in theeyes. The term “B-scan” as used herein may also be used generally torepresent a set of B-scans instead of a single B-scan.

In ophthalmic instances, an A-scan can generally include data from theprecorneal region to the choroid. In some instances, a B-scan caninclude cross-sectional data from a medial border to a lateral border ofthe eye and from the precorneal region to the choroid. In someinstances, a B-scan can include cross-sectional data from a superiorborder to an inferior border of the eye and from the precorneal regionto the choroid. A 3D-OCT can be formed by combining a plurality ofB-scans.

As used herein the terms “user” or “patient” or “subject” may be usedinterchangeably, and the foregoing terms comprise without limitationhuman beings, whether or not under the care of a physician, and othermammals.

The terms “eye scan,” “scanning the eye,” or “scan the eyes,” as usedherein, are broad interchangeable terms that generally refer to themeasurement of any part, substantially all, or all of the eye, includingbut not limited to the pre-cornea, the cornea, the retina, the eye lens,the iris, the vitreous body, the anterior chamber, the anterior chamberangle, the optic nerve, or any other tissue or nerve related to the eye.

The terms “risk assessment” and “diagnosis,” may be used in thespecification interchangeably although the terms have differentmeanings. The term “risk assessment” generally refers to a probability,number, score, grade, estimate, etc. of the likelihood of the existenceof one or more illnesses, diseases, ailments, or the like. The term“diagnosis” generally refers to a determination by examination and/ortests the nature and circumstances of an illness, ailment, or diseasedcondition.

Various methods, systems, and devices may be used to generate andutilize optical coherence tomography image data to perform precisionmeasurements on ocular tissue for the detection of disease features andfindings, and generating a risk assessment and/or diagnosis based ondata obtained by optical coherence tomography imaging techniques. Thesemethods, systems and devices may employ, in some embodiments, astatistical analysis of the detected disease features obtained byoptical coherence tomography imaging techniques. Such methods, systems,and devices can be used to screen for diseases.

With reference to FIG. 1, there is illustrated a block diagram depictingone embodiment of the optical coherence tomography system. In oneembodiment, computer system 104 is electrically coupled to an outputdevice 102, a communications medium 108, and a user card reader system112. The communications medium 108 can enable the computer system 104 tocommunicate with other remote systems 110. The computer system 104 maybe electrically coupled to main body 106, which the user 114 positionsnear or onto the user's eyes. In the illustrated example, the main body106 is a binocular system (for example, has two oculars or optical pathsfor the eyes providing one view for one eye and another view for anothereye, or the like) configured to scan two eyes without repositioning theoculars with respect to the head of the patient, thereby reducing thetime to scan a patient. In some embodiments, the eyes are scannedsimultaneously using a scanner (for example, galvanometer), whichprovides interlaces of measurements from both eyes. Other embodimentsare possible as well, for example, the binocular system or a two ocularsystem having two respective optical paths to the two eyes can beconfigured to scan the eyes in series, meaning one eye first, and thenthe second eye. In some embodiments, serial scanning of the eyescomprises scanning a first portion of the first eye, a first portion ofthe second eye, a second portion of the first eye, and so on.Alternatively, the main body 106 can comprise a monocular system or oneocular system or optical path to the eye for performing eye scans.

Referring to FIG. 1, the user 114 can engage handle 118 and position(for example, up, down, or sideways) the main body 106 that is at leastpartially supported and connected to a zero gravity arm 116, andaccordingly the system 100 has no chin rest. In some embodiments, thisconfiguration can introduce positioning error due to movement of themandible. When the main body 106 is in such a position, the distancebetween the outermost lens (the lens closest to the user) and the user'seye can range between 10 mm and 30 mm, or 5 mm and 25 mm, or 5 mm and 10mm. The close proximity of the lens system to the user's eyes increasescompactness of the system, reduces position variability when the patientplaces his eyes (for example, orbital rims) against the main body 106,and increases the viewing angle of the OCT apparatus when imagingthrough an undilated pupil.

Accordingly, the main body 106 can also comprise eyecups 120 (forexample, disposable eyecups) that are configured to contact the user'seye socket to substantially block out ambient light and/or to at leastpartially support the main body 106 on the eye socket of the user 114.The eyecups 120 have central openings (for example, apertures) to allowpassage of light from the light source in the instrument to the eyes.The eyecups 120 can be constructed of paper, cardboard, plastic,silicon, metal, latex, or a combination thereof. The eyecups 120 can betubular, conical, or cup-shaped flexible or semi-rigid structures withopenings on either end. Other materials, shapes and designs arepossible. In some embodiments, the eyecups 120 are constructed of latexthat conforms around eyepiece portions of the main body 106. The eyecups120 are detachable from the main body 106 after the eye scan has beencompleted, and new eyecups 120 can be attached for a new user to ensurehygiene and/or to protect against the spread of disease. The eyecups 120can be clear, translucent or opaque, although opaque eyecups offer theadvantage of blocking ambient light for measurement in lit environments.

The main body 106 may comprise one or more eyepieces, an interferometer,one or more target displays, a detector and/or an alignment system. Theoptical coherence tomography system may comprise a time domain opticalcoherence tomography system, a spectral, or frequency, domain opticalcoherence tomography system and/or a swept-source optical coherencetomography system. Accordingly, in some embodiments, the main body 106comprises a spectrometer, (for example, a grating) and a detector array.The main body 106 may, in some embodiments, comprise a signal processingcomponent (for example, electronics) for performing, for example,Fourier transforms. Other types of optical coherence tomography systemsmay be employed.

FIG. 2 shows a diagram of an example optical coherence tomographysystem. Light 150 is output from a light source 155. The light source155 may comprise a broadband light source, such as a superluminescentdiode, a microelectromechanical system or a white light source. Lightemitted from the light source 155 may vary in frequency as a function oftime. The light 150 may comprise collimated light. In one embodiment,light 150 from the light source 155 is collimated with a collimatinglens. In another embodiment, two light sources can be used for eachoptical path in the binocular system 106. In yet another embodiment, thelight is split at beam splitter 160. Beam splitters, as describedherein, may comprise, without limitation, a polarization-based beamsplitter, a temporally-based beam splitter, a 50/50 beam splitter and/orother devices and configurations. A portion of the light travels along asample arm, directed towards a sample, such as an eye 165 of a user 114.Another portion of the light 150 travels along a reference arm, directedtowards a reference mirror 170. The light reflected by the sample andthe reference mirror 170 are combined at the beam splitter 160 andsensed either by a one-dimensional photodetector or a two-dimensionaldetector array, such as a charge-coupled device (CCD) or complementarymetal-oxide-semiconductor (CMOS). A two-dimensional array may beincluded in a full field OCT instrument, which may gather informationmore quickly than a version that uses a one dimensional photodetectorarray instead. In time-domain OCT, the length of the reference arm(which may be determined in part by the position of the reference mirror170) may be varying in time.

Whether interference between the light reflected by the sample and thelight reflected by the reference mirror/s occurs will depend on thelength of the reference arm (as compared to the length of the test arm)and the frequency of the light emitted by the light source. Highcontrast light interference occurs between light travelling similaroptical distances (for example, differences less than a coherencelength). The coherence length is determined by the bandwidth of thelight source. Broadband light sources correspond to smaller coherencelengths.

In time-domain OCT, when the relative length of the reference and samplearms varies over time, the intensity of the output light may be analyzedas a function of time. The light signal detected results from light raysscattered from the sample that interfere constructively with lightreflected by the reference mirror/s. Increased interference occurs,however, when the lengths of the sample and reference arms areapproximately similar (for example, within about one coherence length insome cases). The light from the reference arm, therefore, will interferewith light reflected from a narrow range of depths within the sample. Asthe reference (or sample) arms are translated, this narrow range ofdepths can be moved through the thickness of the sample while theintensity of reflected light is monitored to obtain information aboutthe sample. Samples that scatter light will scatter light back thatinterferes with the reference arm and thereby produce an interferencesignal. Using a light source having a short coherence length can provideincreased to high resolution (for example, 0.1-10 microns), as theshorter coherence length yields a smaller range of depths that is probedat a single instant in time.

In various embodiments of frequency-domain optical coherence tomography,the reference and sample arms are fixed. Light from a broadband lightsource comprising a plurality of wavelengths is reflected from thesample and interfered with light reflected by the reference mirror/s.The optical spectrum of the reflected signal can be obtained. Forexample, the light may be input to a spectrometer or a spectrographcomprising, for example, a grating and a detector array, that detectsthe intensity of light at different frequencies.

Fourier analysis performed, for example, by a processor may convert datacorresponding to a plurality of frequencies to that corresponding to aplurality of positions within the sample. Thus, data from a plurality ofsample depths can be simultaneously collected without the need forscanning of the reference arm (or sample) arms. Additional detailsrelated to frequency domain optical coherence tomography are describedin Vakhtin et al., (Vakhtin A B, Kane D J, Wood W R and Peterson K A.“Common-path interferometer for frequency-domain optical coherencetomography,” Applied Optics. 42(34), 6953-6958 (2003)).

Other methods of performing optical coherence tomography are possible.For example, in some embodiment of frequency domain optical coherencetomography, the frequency of light emitted from a light source varies intime. Thus, differences in light intensity as a function of time relateto different light frequencies. When a spectrally time-varying lightsource is used, a detector may detect light intensity as a function oftime to obtain optical spectrum of the interference signal. The Fouriertransform of the optical spectrum may be employed as described above. Awide variety of other techniques are also possible.

FIG. 3A shows one configuration of main body 106 comprising an opticalcoherence tomography system and an alignment system. Other opticalcoherence tomography systems and/or alignment systems may be included inplace of or in addition to the systems shown in FIG. 3A. As shown, themain body 106 can include two eyepieces 203, each eyepiece configured toreceive an eye from a user 114. In various embodiments, the main body106 includes only one eyepiece 203.

FIG. 3A shows one representative embodiment of an optical coherencetomography system. Light from a light source 240 may propagate along apath that is modulated, for example, vertically and/or horizontally byone or more beam deflectors 280. (Alternatively, the light from thelight source can travel down and/or be modulated by fiber optics,microfiber, and/or any other medium capable of transmitting/modulatinglight.) A galvanometer may be used for this purpose. The galvanometer280 can control the horizontal and/or vertical location of a light beamfrom the light source 240, thereby allowing a plurality of A-scans (andthus one or more B-scan and/or a 3D-OCT) to be formed.

The light from the light source 240 is split at beam splitter 245. Insome embodiments, beam splitter 245 is replaced by a high frequencyswitch that uses, for example, a galvanometer, that directs about 100%of the light towards mirror 250 a for about ½ of a cycle and thendirects about 100% of the light towards mirror 250 b for the remainderof the cycle. The light source 240 may include a broadband light source,such as a superluminescent light-emitting diode or amicroelectromechanical tunable laser source. Light split at the beamsplitter 245 is then split again at beam splitter 285 a or 285 b to forma reference arm and a sample arm. A first portion of the light split atbeam splitter 285 a or 285 b is reflected by reference mirrors 273 a or273 b, reference mirrors 270 a or 270 b, and reference mirrors 265 a or265 b. A second portion of the light split at beam splitter 285 a or 285b is reflected by mirror 250 a or 250 b, by mirror 255 a or 255 b and bymirror 260 a or 260 b. Mirrors 255 a or 255 b and mirrors 250 a and 250b are connected to a Z-offset adjustment stage 290 b. By moving theposition of the adjustment stage 290 a or 290 b, a different portion ofthe eye can be imaged. Thus, the adjustment stage 290 a or 290 b canadjust the difference between the optical length from the light source240 to a portion of the sample and the optical length from the lightsource 240 and the reference mirror 270 a or 270 b and/or referencemirror 273 a or 273 b. This difference can be made small, for example,less than a coherence length, thereby promoting optical interference tooccur. In some embodiments, the positions of one or more referencemirrors (for example, reference mirror 270 a or 270 b and referencemirror 273 a or 273 b) are movable in addition to or instead of theadjustment stage being movable. Thus, the length of the reference armand/or of the sample arm may be adjustable. The position of theadjustment stages 290 a and/or 290 b may be based on the signals fromthe device, as described in more detail below.

The light reflected by mirror 260 a or 260 b is combined with light fromdisplay 215 a or 215 b at beam splitter 230 a or 230 b. The displays 215a and 215 b may comprise one or more light sources, such as in anemissive display like an array of matrix LEDs. Other types of displays,such as LCD, FFD or FLCOS displays, can be used. The display can displaytargets of varying shapes and configurations, including a bar and/or oneor more dots. It can also be configured to display images or movies. Aportion of the optical path from the light source 240 to the eye may becoaxial with a portion of the path from the displays 215 a and 215 b tothe eye. These portions may extend though the eyepiece. Accordingly, alight beam from the light source 240 is coaxial with a light beam fromthe displays 215 a and 215 b such that the eyes can be positioned andaligned with respect to the eyepieces using the displays. A lens may beplaced in the light path between display 215 a and element 220 a (or 215b and 220 b) to enable manipulation of the vergence of light emittedfrom the display wherein the target appears at a large distance (forexample, infinity). In many configurations, collimated light may bedesirable. In others, divergent light simulating a near target may bedesirable. In some embodiments, therefore, one or more lenses areinterposed in the light path between elements 260 a and 230 a or 260 band 230 b to produce the same vergence effect on the light from lightsource 240. Mirrors, prisms, or other optical elements may be used, incertain embodiments, to provide increased optical path for insertion ofthe one or more lenses. In certain embodiments, the one or more lensescan be Stokes' lenses. The display may be used for a variety of tests,such as functional tests where controlled eye fixation is used.Additional discussion of such tests is provided below.

As described in greater detail below, for example, the user 114 may useimages from the displays in order to adjust interpupillary distance. Invarious embodiments, for example, proper alignment of two imagespresented by the displays may indicate that the interpupillary distanceis appropriately adjusted. Thus, one or more adjustment controls 235 maybe used to adjust the distance between the display targets 215 a and 215b and/or between the eyepieces 203. The adjustment controls 235 may beprovided on the sides of the main body 106 or elsewhere. In certainembodiments, the adjustment control 204 may comprise a handle on themain body 106, as shown in FIG. 3B. In this embodiment, rotation of theadjustment control 204 may increase or decrease the interpupillarydistance. In various embodiments, the adjustment control 204 may becontrolled electronically by processors within the main body 106 basedon the detected position of the pupils, the iris in one eye or botheyes, or lens region in at least one eye, by using, for example, edgedetection algorithms, from B-scans or C-scans of the anterior chamber.In certain embodiments, the interpupillary distance can be adjusted bycontrol 204 until the pupils are substantially centered in both B-scansor C-scans, thereby indicating optimal optical axis alignment. Incertain embodiments, the interpupillary distance can be adjusted in twoaxes (horizontal and vertical). Additional discussion of electronicinterpupillary distance adjustment is provided below in the section onpupillometry.

The combined light (that is reflected by mirror 260 a or 260 b and thatcomes from display 215 a or 215 b) is focused by adjustable poweredoptics (for example, lens) 210 possibly in conjunction with opticalelement 205. The adjustable optics 210 may comprise a zoom lens or lenssystem that may have, for example, a focal length and/or power that isadjustable. The adjustable optics 210 may comprise or be part of anauto-focus system or may be manually adjusted. The adjustable optics 210may provide optical correction for those in need of such correction (forexample, a user whose glasses are removed during testing). The positionof the powered optics 210 may be based on the signals obtained from thedevice, as described in more detail below. The focused light thentravels through eyepiece windows or lens 205, positioned at a proximalend of the eyepiece 203, towards the eye of a user 114. In the casewhere a lens 205 is included, this lens 205 may contribute to focusingof the light into the eye.

This light directed into the eye may be scattered by tissue or featurestherein. A portion of this scattered light may be directed back into theeyepiece. Lens 205 may thus receive light 207 reflected from the user'seye, which travels through the powered optics 210, reflects off of thebeam splitter 230 a or 230 b towards beam splitter 220 a or 220 b, whichreflects the light towards mirrors 295 a or 295 b. At 295 a or 295 b,light reflected by the sample interferes with light in the reference arm(path between beam splitter 285 a or 285 b and beam splitter 295 a or295 b that includes mirrors 273 a or 273 b and 270 a or 270 b).(Accordingly, the sample arm includes the optical path between beamsplitter 285 a or 285 b and beam splitter 295 a or 295 b that includesmirrors 250 a or 250 b and 255 a or 255 b and the sample or eye.) Thelight is then reflected by mirror 225 a or 225 b towards switch 275. Insome embodiments, the switch 275 comprises a switchable deflector thatswitches optical paths to the first or second eye to collect data fromthe respective eye to be sent to the data acquisition device 202. Theswitch may comprise a low-frequency switch, such that all data to becollected from one eye is obtained before the data is collected from theother eye. Alternatively, the switch may comprise a high-frequencyswitch, which may interlace data collected from each eye.

The instrument may be configured differently. For example, a commonreference path may be used for each eye. In some embodiments, thereference arm includes one or more movable mirrors to adjust the opticalpath length difference between the reference and sample arms. Componentsmay be added, removed, or repositioned in various embodiments. Othertechniques, may be used.

Although not shown, for example, polarizers and polarizing beamssplitters may be used to control the propagation of light through theoptical path in the optical system. Other variations are possible. Otherdesigns may be used.

In some embodiments, an A-scan may be formed in the time domain. Inthese instances, the Z-offset adjustment stage and corresponding mirror250 a or 250 b and mirror 255 a or 255 b may change positions in time.Alternatively, reference mirrors 270 a and 270 b and reference mirrors273 a and 273 b or other mirrors in the reference or sample arms may betranslated. The combined light associated with various mirror positionsmay be analyzed to determine characteristics of an eye as a function ofdepth. In various embodiments, an A-scan may be formed in the spectraldomain. In these instances, the frequencies of the combined light may beanalyzed to determine characteristics of an eye as a function of depth.Additionally, one or more galvanometers 280 can control the horizontaland/or vertical location of the A-scan. Thus, a plurality of A-scans canbe obtained to form a B-scan and/or a 3D-OCT scan.

Light output from the structure 275 can be input into a data acquisitiondevice 202, which may comprise, for example, a spectrometer, aphotodetector, or a light meter. A grating may be in the main body 106.The data acquisition device 202 is coupled to a computer system 104,which may present output based on scans to the user 114. The outputdevice may include a monitor screen, in which output results aredisplayed. The output device may include a printer, which prints outputresults. The output device may be configured to store data on a portablemedium, such as a compact disc or USB drive, or a custom portable datastorage device.

In some embodiments, the computer system 104 analyzes data received bythe data acquisition device 202 in order to determine whether one ormore of the adjustment stages 290 a and/or 290 b and/or one or moremovable components and/or the powered optics 210 should be adjusted. Inone instance, an A-scan is analyzed to determine a position (forexample, a coarse position) of the retina such that data on the retinamay be obtained by the instrument. In some embodiments, each A-scancomprises a plurality of light intensity values, each associated with adifferent depth into the sample. The A-scan may be obtained, in someembodiments, by translating the Z adjustment stage 290 a or 290 b.Likewise, the A-scan comprises values of reflected signal obtained atdifferent locations of the Z adjustment stage. The retina reflects morelight than other parts of the eye, and thus, it is possible to determinea position of the adjustment stage 290 a or 290 b that effectivelyimages the retina by assessing what depths provide an increase inreflected intensity. In some embodiments, the Z adjustment stage may betranslated and the intensity values may be monitored. An extended peakin intensity for a number of Z adjustment stage positions may correspondto the retina. A variety of different approaches and values may bemonitored to determine the location of the retina. For example, multipleA-scans may be obtained at different depths and the integrated intensityof each scan may be obtained and compared to determine which depthprovided a peak integrated intensity. In certain embodiments, intensityvalues within an A-scan can be compared to other values within theA-scan and/or to a threshold. The intensity value corresponding to thepreferred location may be greater than a preset or relative thresholdand/or may be different from the rest of the intensity values, (forexample, by more than a specified number of standard deviations). A widevariety of approaches may be employed.

After the positions of the adjustment stages 290 a and 290 b have beendetermined, subsequent image analysis may be performed to account forvibration or movement of the user's head, eyes or retinas relative tothe light source 240. A feedback system such as a closed loop feedbacksystem may be employed in effort to provide a more stabilized signal inthe presence of such motion. The optical coherence tomography signal maybe monitored and feedback provided to, for example, one or moretranslation stages to compensate for such vibration or movement. In oneembodiment, the positions of tissue features identified fromnon-interferometric light reflected from the subject's eye are trackedto determine the movement of the subject's eye. This movement can thenbe compensated for by modifying the galvanometer movements to correctfor underlying eye movements. In some embodiments, subsequent imageanalysis may be based on initial image and/or detect changes in imagecharacteristics. For example, the image analysis may determine that thebrightest pixel within an A-scan has moved 3 pixels from a previousscan. The adjustment stage 290 a or 290 b may thus be moved based onthis analysis. Other approaches may be used.

In some instances, optical coherence tomography signals are used toadjust the powered optics 210 to provide for increased or improvedfocus, for example, when a patient needs refractive correction. Manyusers/patients, for example, may wear glasses and may be tested whilenot wearing any glasses. The powered optics 210 may be adjusted based onreflected signal to determine what added correction enhances signalquality or is otherwise an improvement. Accordingly, in someembodiments, a plurality of A-scans is analyzed in order to determine aposition for the powered optics 210. In some instances, a plurality ofA-scans is analyzed in order to determine a position for the poweredoptics 210. In some embodiments, this determination occurs after theposition of the adjustment stage 290 a or 290 b has been determined. Oneor more A-scans, one or more B-scans or a 3D-OCT may be obtained foreach of a plurality of positions of the powered optics 210. These scansmay be analyzed to assess, for example, image quality. The position ofthe powered optics 210 may be chosen based on these image qualitymeasures.

The image quality measure may include a noise measure. The noise measuremay be estimated based on the distribution of different intensity levelsof reflected light within the scans. For example, lower signals may beassociated with noise. Conversely, the highest signals may be associatedwith a saturated signal. A noise measure may be compared to a saturationmeasure as in signal to noise ratios or variants thereof. The lowestreflectivity measured (referred to as a low measure or low value) mayalso be considered. In some embodiments, the positions of the adjustmentstages 290 a and/or 290 b and/or the powered optics 210 is determinedbased upon a signal-to-noise measure, a signal strength measure, a noisemeasure, a saturation measure, and a low measure. Different combinationsof these parameters may also be used. Values obtained by integratingparameters over a number of positions or scans, etc., may also be used.Other parameters as well as other image quality assessments may also beused.

In one embodiment, a noise value is estimated to be a reflected lightvalue for which approximately 75% of the measured reflected light isbelow and approximately 25% of the measured reflected light is above.The saturation value is estimated to be a reflected light value forwhich approximately 99% of the measured reflected light is below andapproximately 1% of the measured reflected light is above. A middlevalue is defined as the mean value of the noise value and the saturationvalue. An intensity ratio is defined as the difference between thesaturation value and the low value divided by the low value multipliedby 100. A tissue signal ratio is defined as the number of reflectedlight values between the middle value and the saturation value dividedby the number of reflected light values between the noise value and thesaturation value. A quality value is defined as the intensity ratiomultiplied by the tissue signal ratio. Additional details are described,for example, in Stein D M, Ishikawa H, Hariprasad R, Wollstein G,Noecker R J, Fujimoto J G, Schuman J S. A new quality assessmentparameter for optical coherence tomography. Br. J. Ophthalmol. 2006; 90;186-190. A variety of other approaches may be used to obtain a figure ofmerit to use to measure performance and adjust the instrumentaccordingly.

In the case of adjusting the adjustable power optics, 210, in someembodiments, a plurality of positions are tested. For example, thepowered optics may be continuously moved in defined increments towardsthe eyes for each scan or set of scans. Alternatively, the plurality ofpositions may depend on previously determined image quality measures.For example, if a first movement of the powered optics 210 towards theeye improved an image quality measure but a subsequent second movementtowards the eye decreased an image quality measure, the third movementmay be away from the eye. Accordingly, optical power settings may beobtained that improve and/or maintains an improved signal. This opticalpower setting may correspond to optical correction and increase focus ofthe light beam in the eye, for example, on the retina, in someembodiments.

As described above, various embodiments employ an arrangement wherein apair of oculars is employed. Accordingly, such adjustments, may beapplied to each of the eyes as a user may have eyes of different sizeand the retina may located at different depths and thus a pair of zadjust stages may be used in some embodiments. Similarly, a user mayhave different prescription optical correction for the different eyes. Avariety of arrangements may be employed to accommodate such needs. Forexample, measurements and/or adjustments may be performed and completedon one eye and subsequently performed and completed the other eye.Alternatively, the measurements and/or adjustments may be performedsimultaneously or interlaced. A wide variety of other variations arepossible.

FIG. 4 shows a diagram of a spectrometer 400 that can be used as a dataacquisition device 202 for a frequency domain OCT system. Light 405input into the spectrometer 400 is collected by collecting lens 410. Thecollected light then projects through a slit 415, after which it iscollimated by the collimating lens 420. The collimated light isseparated into various spectral components by a grating 425. The grating425 may have optical power to focus the spectral distribution onto animage plane. Notably, other separation components, such as a prism maybe used to separate the light. The separated light is then directed ontoa detector array by focusing lens 430, such that spectral components ofeach frequency from various light rays are measured.

A wide variety of OCT designs are possible. For example, frequency canbe varied with time. The reference and sample arms can overlap. In someembodiments, a reference arm is distinct from a sample arm, while invarious embodiments, the reference arm and sample arm are shared. See,for example, Vakhtin A B, Kane D J, Wood W R and Peterson K A.“Common-path interferometer for frequency-domain optical coherencetomography,” Applied Optics. 42(34), 6953-6958 (2003). The OCTarrangements should not be limited to those described herein. Othervariations are possible.

In some embodiments, as shown in FIG. 5, the main body 106 includes onlya single display target 215. Light from the display target 215 is splitat an x-prism 505. Notably, other optical devices that split the sourcelight into a plurality of light rays may be used. This split light isreflected at mirror 510 a or 510 b and directed towards the user 114.

The user may be directed to fixate on a display target 215 while one ormore galvanometers 280 move light from the light source 240 to image anarea of tissue. In some embodiments, the display targets 215 are movedwithin the user's field of vision while an area of tissue is imaged. Forexample, in FIG. 6A, a display target 215 may be moved horizontally (forexample, in the medial-lateral direction), such that a patient isdirected to look from left to right or from right to left. Meanwhile, avertical scanner (for example, galvanometer) allows the verticallocation (for example, in the superior-inferior) of the sample scanningto change in time. FIG. 6 shows an eye, which is directed to move in thehorizontal direction 605. Due to the vertical scanner, the scannedtrajectory 610 covers a large portion of the eye 600. Scanning in thevertical and horizontal directions can produce a 3D-OCT scan. In someembodiments, continuous and/or regularly patterned A-scans are combinedto form a full scan for example, B-scan or 3D-OCT scan. In variousembodiments, discrete and/or random A-scans are combined to form thefull scan. Systems configured such that users 114 are directed to movetheir eyes throughout a scan may include fewer scanners than comparablesystems configured such that users 114 keep their eyes fixated at astationary target. For example, instead of a system comprising both avertical and a horizontal scanner, the user 114 may move his eyes in thehorizontal direction, thereby eliminating the need for a horizontalscanner.

In various embodiments, two scanners (for example, a vertical and ahorizontal scanner) can be used. The design, capabilities and/orspecifications for these scanners need not be the same. For example, oneof the scanners may be faster and/or higher resolution than the other.Specifically, a vertical scanner may be used that scans more rapidlythan a horizontal scanner, or vice versa. Scanners such as galvanometershaving different speeds may be used in some example embodiments to scancontinuously in the vertical direction and only occasionally incrementalong the horizontal (or vice versa). In some embodiments, for example,one of the scanners may be ½ to 1/500 as fast as the other scanneralthough values outside this range are possible. Similarly, in someembodiments, the 3D-OCT image may not contain as many pixels in onedirection (for example horizontal) as the other direction (for example,vertical). In some embodiments, for example, the 3D-OCT image may be600×512 although other sizes are possible. Likewise, one scanner orgalvanometer may have a reduced resolution compared to the otherscanner. In instances wherein the specifications for one scanner includeslower scan rates or less resolution than the other scanner, possibly aless expensive scanner or galvanometer may be used. Accordingly, the twoscanners or galvanometers need not be the same type or grade. Arelatively high performance (higher cost) and a relatively lowerperformance (lower cost) scanner may be used. Use of a lowerperformance/cost scanner or galvanometer instead of two scanners orgalvanometers of equal quality and cost may reduce the overall cost ofthe instrument. Other variations are also possible. Some embodimentsdisclosed herein refer to one or more galvanometers. In someembodiments, a different kind of scanner may be used in place of thegalvanometer.

FIG. 6B shows an example of an A scan. The A scan comprises the signalstrength (indicated by the brightness) as a function of depth for onehorizontal and vertical position. Thus, an A-scan comprises a pluralityof intensity values corresponding to different anterior-posteriorpositions. A plurality of A scans form a B scan. FIG. 6C shows a B-scan,in which the largest portion of the bright signal corresponds to retinaltissue and the elevated region under the retina corresponds to diseasedtissue within the eye.

With reference to FIG. 7A, there is illustrated an enlarged viewdepicting an embodiment of the main body 106 that is configured with ahandle 118 for adjusting the eyepieces to conform to the user'sinterpupillary distance. In the illustrative embodiment, the main body106 comprises a left eyepiece 712 and a right eyepiece 714 wherein eachis connected to the other by interpupillary distance adjustment device718. The interpupillary distance adjustment device 718 is coupled to thehandle 118, wherein the handle 118 is configured to allow the user toengage the handle 118 to adjust the distance between the left and righteyepieces 712, 714 to match or substantially conform to theinterpupillary distance between the eyes of the user.

Referring to FIG. 7A, the user can rotate, turn, or twist the handle 118to adjust the distance between the left and right eyepieces 712, 714 soas to match or substantially conform to the interpupillary distancebetween the eyes of the user. Alternatively, the handle 118 can beconfigured to move side to side to allow the user to adjust the distancebetween the left and right eyepieces 712, 714. Additionally, the handle118 can be configured to move forward and backward to allow the user toadjust the distance between the left and right eyepieces 712, 714. Inthe alternative, the handle 118 can be configured to move up and down toallow the user to adjust the distance between the left and righteyepieces 712, 714. In another embodiment, the distance between the leftand right eyepieces 712, 714 can be adjusted and/or controlled by amotor activated by the user. Alternatively, the motor can be configuredto be controlled by computer system 104 to semi-automatically positionthe left and right eyepieces 712, 714 to match the interpupillarydistance between the eyes of the user. In these instances, eye trackingdevices may be included with a system described herein. In variousembodiments, a combination of the foregoing are utilized to adjust thedistance between the left and right eyepieces 712, 714 to match orsubstantially conform to the user's interpupillary distance.

A user 114 may adjust interpupillary distance based on the user'sviewing of one or more fixation targets on one or more displays 215. Forexample, the displays 215 and the fixation targets may be configuredsuch that the user views two aligned images, which may form a single,complete image when the interpupillary distance is appropriate for theuser 114. The user 114 may adjust (for example, rotate) an adjustmentcontrol 204 to change the interpupillary distance based on the fixationtarget images, as shown in FIG. 7A. FIGS. 7B-7F illustrate oneembodiment of fixation targets as seen by the viewer under a pluralityof conditions; however, other fixation targets are possible, includingbut not limited to a box configuration. FIG. 7B shows a U-shapedfixation target 715 a on the display 215 a for the left eye. FIG. 7Cshows an upside-down U-shaped fixation target 715 b on the display 215 bfor the right eye.

When the interpupillary distance is appropriately adjusted, the bottomand top images 715 a and 715 b are aligned, as shown in FIG. 7D to forma complete H-shaped fixation target 715. When the interpupillarydistance is too narrow, the fixation target 715 a on the display 215 afor the left eye appear shifted to the right and the fixation target onthe display 215 b for the right eye appear shifted to the left and theuser sees the image shown in FIG. 7E. Conversely, when theinterpupillary distance is too wide, the fixation target 715 a on thedisplay 215 a for the left eye appear shifted to the left and thefixation target on the display 215 b for the right eye appear shifted tothe right and the user sees the image shown in FIG. 7F. Thus, theinterpupillary distance may be adjusted based on these images.

In particular, in FIG. 7D, the alignment image 715 is in the shape of an“H.” Thus, when the interpupillary distance is properly adjusted, thefixation targets on the left and right displays overlap to form an “H”.Other alignment images 715 may be provided.

In another embodiment, B-scans or C-scans through the iris plane in eacheye can demonstrate the location of the pupil, or light entrance to theback of the eye. Image analysis routines, such as edge detection, couldbe applied to these B-scan or C-scan images to detect the borders of thepupil in each eye. The computer system 104 can be configured toautomatically adjust the interpupillary distance to center thesepupillary borders in the center of the B-scan or C-scan on each side.

With reference to FIG. 8, there is illustrated an embodiment of thecomputer system 104. In the illustrated embodiment, the computer system104 can comprise a scan control and analysis module 824 configured tocontrol the scanning operations performed by the main body 106. Thecomputer system 104 can also comprise a fixation marker control system822 configured to display a fixation marker visible by the user frommain body 106. In certain embodiments, the fixation marker is displayedas an “X,” a dot, a box, or the like. The fixation marker can beconfigured to move horizontally, vertically, diagonally, circularly, ora combination thereof. The fixation marker can be repositioned quicklyto relocate the beam location on the retina as the eye repositionsitself. The computer system 104 can also comprise a focus adjust module820 for automatically adjusting the focusing lenses in the main body 106as further discussed herein. The computer system 104 can also comprise aZ positioning module 818 for automatically adjusting the Z offset asherein discussed.

Referring to FIG. 8, the computer system 104 comprises in theillustrative embodiment a disease risk assessment/diagnosis module 808for storing and accessing information, data, and algorithms fordetermining, assessing the risk or likelihood of disease, and/orgenerating a diagnosis based on the data and/or measurements obtainedfrom scanning the eyes of the user. In one embodiment, the scan controland analysis module 824 is configured to compare the data received fromthe main body 106 to the data stored in the disease riskassessment/diagnosis module 808 in order to generate a risk assessmentand/or diagnosis of disease in the eyes of the user as furtherillustrated. The computer system 104 can also comprise an image/scansdatabase configured to store images and/or scans generated by the mainbody 106 for a plurality of users, and to store a unique identifierassociated with each image and/or scan. In certain embodiments, the scancontrol and analysis module 824 uses historical images and/or scans of aspecific user to compare with current images and/or scans of the sameuser to detect changes in the eyes of the user. In certain embodiments,the scan control and analysis module 824 uses the detected changes tohelp generate a risk assessment and/or diagnosis of disease in the eyesof the user.

In the illustrative embodiment shown in FIG. 8, the computer system 104can comprise a user/patient database 802 for storing and accessingpatient information, for example, user name, date of birth, mailingaddress, residence address, office address, unique identifier, age,affiliated doctor, telephone number, email address, social securitynumber, ethnicity, gender, dietary history and related information,lifestyle and/or exercise history information, use of corrective lens,family health history, medical and/or ophthalmic history, priorprocedures, or other similar user information. The computer system 104can also comprise a database of biometric markers, such as the retinalvessel pattern or other measurements made from eye tissues. In certainembodiments, the database of biometric markers can be used to determineor verify the identity of a user for authentication, for follow-upcomparisons, and/or for other like purposes. The computer system 104 canalso comprise a physician referral database for storing and accessingphysician information, for example, physician name, physician trainingand/or expertise/specialty, physician office address, physiciantelephone number and/or email address, physician schedulingavailability, physician rating or quality, physician office hours, orother physician information.

In reference to FIG. 8, the computer system 104 can also comprise a userinterface module 805 (which can comprise without limitation commonlyavailable input/output (110) devices and interfaces as described herein)configured to communicate, instruct, and/or interact with the userthrough audible verbal commands, a voice and/or speech recognitioninterface, a key pad, toggles, a joystick handle, switches, buttons, avisual display, touch screen display, etc. or a combination thereof. Incertain embodiments, the user interface module 805 is configured toinstruct and/or guide the user in utilizing and/or positioning the mainbody 106 of the optical coherence tomography system 100. The computersystem 104 can also comprise a reporting/output module 806 configured togenerate, output, display, and/or print a report (for example, FIGS. 10Aand 10B) comprising the risk assessment and/or diagnosis generated bythe disease risk assessment/diagnosis module 808. In variousembodiments, the report comprises at least one recommended physician tocontact regarding the risk assessment.

Referring to FIG. 8, the computer system 104 can also comprise anauthentication module 816 for interfacing with user card reader system112, wherein a user can insert a user identification card into the usercard reader system 112. In certain embodiments, the authenticationmodule 816 is configured to authenticate the user by reading the datafrom the identification card and compare and/or store the informationwith the data stored in the user/patient database 802. In certainembodiments, the authentication module 816 is configured to read orobtain the user's insurance information from the user's identificationcard through the user card reader system 112. The authentication module816 can be configured to compare the user's insurance information withthe data stored in the insurance acceptance database 828 to determinewhether the user's insurance is accepted or whether the user's insurancecompany will pay for scanning the user's eyes. In various embodiments,the authentication module communicates with the billing module 810 tosend a message and/or invoice to the user's insurance company and/ordevice manufacturer to request payment for performing a scan of thepatient's eyes. The card can activate one or more functions of themachine allowing the user, for example, to have a test performed orreceive output from the machine. In various embodiments, the billingmodule 810 is configured to communicate with the user interface module805 to request payment from the user to pay for all or some (forexample, co-pay) of the cost for performing the scan. In certainembodiments, the billing module 810 is configured to communicate withthe user card reader system 112 to obtain card information from theuser's credit card, debit card, gift card, or draw down credit stored onthe user's identification card. Alternatively, the billing module 810 isconfigured to receive payment from the user by communicating and/orcontrolling an interface device for receiving paper money, coins,tokens, or the like. Alternatively, the billing module 810 is configuredto receive payment from the user by communicating with the user's mobiledevice through Bluetooth® or other communications protocols/channels inorder to obtain credit card information, billing address, or to chargethe user's mobile network service account (for example, the cellularcarrier network).

With reference to FIG. 8, the user card may be used by insurers to trackwhich users have used the system. In one embodiment, the system canprint (on the face of the card) or store (in a chip or magnetic stripe)the scan results, risk assessment, and/or report directly onto or intothe card that the patient inserts into the system (wherein the card isreturned to the user). The system can be configured to store multiplescan results, risk assessments, and/or reports, and/or clear prior scanresults, risk assessments, and/or reports before storing new informationon the magnetic stripe. In certain embodiments, the calculation of therisk assessment is performed by the system (for example, scanninganalysis module 824). In certain embodiments, the calculated riskassessment is transmitted a centralized server system (for example,remote systems 110) in another location that provides the results via aweb page to physicians, users, patients, or the like. The centralizedserver system (for example, remote system 110) allows the user,patients, or doctors to enter their card code to see the results whichare saved in the centralized database.

In the example embodiment of FIG. 8, the computer system 104 cancomprise a network interface 812 and a firewall 814 for communicatingwith other remote systems 110 through a communications medium 108. Otherremote systems 110 can comprise without limitation a system for checkingthe status/accuracy of the optical coherence tomography system 100; asystem for updating the disease risk assessment/diagnosis database 808,the insurance acceptance database 828, the physician referral database804, and/or the scan control and analysis module 824. In certainembodiments, the computer system 104 can be configured to communicatewith a remote system 110 to conduct a primary and/or secondary riskassessment based on the data from scanning the user's eyes with the mainbody 106.

Referring to FIG. 8, the remote system 110 can be configured to remotelyperform (on an immediate, delayed, and/or batch basis) a risk assessmentand/or diagnosis and transmit through a network or communications mediumthe risk assessment, diagnosis, and/or report to the computer system 104for output to the user using output device 102. In certain embodiments,the output device 102 is configured to display the risk assessment,diagnosis, and/or report as a webpage that can be printed, emailed,transmitted, and/or saved by the computer system 104. The remote system110 can also be configured to transmit through a network orcommunications medium the risk assessment, diagnosis, and/or report tothe user's (or doctor) cellular phone, computer, email account, fax, orthe like.

With reference to FIG. 9, there is shown an illustrated method of usingthe optical coherence tomography system 100 to self-administer an OCTscan of the user's eyes and obtain a risk assessment or diagnosis ofvarious diseases and ailments. The process begins at block 901 whereinthe user approaches the optical coherence tomography system 100 andactivates the system, by for example pushing a button or typing in anactivation code or anonymous identification number. In variousembodiments, the user interface module 805 instructs users at block 901to first insert an identification card or anonymous coded screening cardin user card reader system 112 to activate the system. The system canalso be activated at block 901 when users insert their useridentification card in user card reader system 112. Other means ofactivating the system are possible as well as, including withoutlimitation, a motion sensor, a weight sensor, a radio frequencyidentification (RFID) device, or other actuator to detect the presenceof the user. Alternatively, the optical tomography system 100 can beactivated when the billing module 810 detects that the user has insertedpaper money, coins, tokens, or the like into an interface deviceconfigured to receive such payment. Alternatively, the billing module810 can also be configured to activate the optical tomography system 100when the billing module 810 communicates with a user's mobile device inorder to obtain the user's credit card information, billing address, orthe like, or to charge the user's mobile network service account (forexample, the cellular carrier network)

In referring to FIG. 9 at block 902, the user interface module 805 isconfigured to direct the user to attach disposable eyecups onto the mainbody 106, and then position the main body 106 with the disposableeyecups near the eyes of the user and/or support the disposable eyecupsagainst the user's eye socket. The user interface module 805 instructsthe user to engage handle 118 to adjust the distance between the leftand right eyepieces 612, 614 to match or substantially conform to theinterpupillary distance of the user as described with respect to FIGS.6A-6F. After the main body 106 and the interpupillary distance has beenappropriately calibrated and/or adjusted by the user, the user inputsinto or indicates to the user interface module 805 to begin the scan.The scan control and analysis module 824 substantially restrictsmovement or locks the position of the zero gravity arm and/or thedistance between the left and right tubes 612, 614 to begin the scan.

Referring to FIG. 9, the Z module 818 automatically adjusts the z-offsetin the main body 106 at block 906 such that the OCT measurement will beobtained, for example, from tissue in the retina. The Z module 818 mayidentify and/or estimate a position of part of the sample (for example,part of an eye of a user 114) and adjust the location of one or moreoptical components based on the position. One of ordinary skill in theart will appreciate the multitude of ways to perform such an adjustment.For example, the Z module 818 may comprise a motor, such as apiezoelectric motor, to translate the reference mirror/s longitudinallysuch that the optical path length from the beam splitter to the retinais about equal to (within a coherence length of) the optical path lengthin the reference arm. This movement may enable light from the referencearm to interfere with light reflected by a desired portion of the sample(for example, the retina). At block 908, the illustrative methodperforms a focus adjustment using the focus adjustment module 820. Thoseof ordinary skill in the art will also appreciate the differenttechniques for performing such auto-focus calibration. Block 910illustrates an optional test performed by the computer system 104 todetermine the visual function and acuity of the user's eye. In certainembodiments, the visual acuity test works with or is combined with thefixation marker control system 722, and can test both eyessimultaneously or one eye at time. For example, the fixation marker willinitially appear small and then gradually increase in size until theuser indicates through the user interface module 705 that the fixationmarker is visible. Based on the size at which the user can clearly seethe fixation marker, fixation marker control system 722 can estimate ordetermine or assess the visual acuity of the user's eyes (for example,20/20, 20/40, or the like). In some embodiments, visual acuity can beestimated by measuring or evaluating the stability of fixation usingcross-correlations of neighboring B-scans or changes in fundusreflectivity due to eye movements measured with a scanning laser lightsource. Generally, when acuity is decreased, an eye may move more oftenand in greater amplitudes. For example, one way to detect greater eyemovements and/or eye movements having greater amplitudes is tocross-correlate B-scans that are supposed to be next to each other. WhenB-scans are next to each other, the cross-correlation will generally behigh since the data does not generally change significantly. However,when the eye has moved a significant distance, the cross-correlationwill be lower since there will generally be more change in the features.In some embodiments, the system can be configured to detect eyemovements by imaging the retina with scanning laser illumination andcomparing adjacent images in time for mutual information or to determinemovement of retinal features, such as retinal vessels, the optic nerve,SIFT features, or other information-based features.

With reference to FIG. 9 at Block 912, the user interface module 805instructs the user to follow the movement of the fixation marker that isvisible to the user from the main body 106. In one embodiment, thefixation marker control 822 is configured to display a fixation markerthat moves horizontally. In some embodiments, the horizontal movement ofthe fixation marker allows the scan control and analysis module 824 toscan the eye vertically as the eye moves horizontally, thus possiblyobtaining a two-dimensional, volume, or raster scan of the eye tissue atissue. Alternatively, the scan control and analysis module 824 and/orthe fixation marker control may cause the fixation marker or the beam tojump or move around to obtain measurements at different laterallocations on the eye.

During the scanning of the eye, the scan control and analysis module 824could be configured to detect at block 913 whether there has been ashift in the position of the main body 106 relative to the user. In oneembodiment, the scan control and analysis module 824 can detect (inreal-time, substantially real-time, or with a delay) whether a shift hasoccurred based on what the values the module 824 expects to receiveduring the scanning process. For example, as the scan control andanalysis module 824 scans the retina, the module 824 expects to detect achange in signal as the scanning process approaches the optic nerve (forexample, based on the location of the fixation target and/or state ofthe scanner(s)). Alternatively, the expected values or the expectedchange in values can also be determined or generated using a nomogram.If the system does not detect an expected signal change consistent witha detection of the optic nerve and/or receives no signal change, thenthe module 824 can be configured to interpret such data as the user isnot tracking properly. Other features, for example, the fovea, or thelike, can be used to determine whether the expected signal is observed.If improper tracking occurs enough (based on, for example, a threshold),the system 100 may request that the user fixate again (using fixationmarker control 822) for another scan. If the foregoing shift detectionprocess does not occur in real-time or substantially real-time, then thesystem can be configured to complete the scan, perform data analysis,and during the analysis the system can be configured to detect whether ashift occurred during the scan. If a substantial shift is detected, thenthe user may be instructed (through visual, audible, or verbalinstructions using the user interface module 805) to sit forward againso another scan can be performed. If the system detects a shift 2 or 3or more times, the system can be configured to refer the user to ageneral eye doctor.

At the end of a scan, the scan control and analysis module 824 can beconfigured to produce a confidence value that indicates how likely thenomograms will be to apply to this patient. For example, if the patienthad borderline fixation, the confidence value might be lower than apatient whose fixation appeared to be good.

In the real-time embodiment, the system can be configured to performrapid cross-correlations between adjacent A-scans or B-scans to makesure the eye is moving somewhat. In some embodiments, the foregoing canbe advantageous for ANSI laser safety standards so as to avoid havingusers stare at the same location with laser energy bombarding the user'sretina. Accordingly, in some embodiments, the system is configured witha laser time-out feature if the system detects no eye moment (forexample, cross-correlations above a certain threshold). In someembodiments, to expedite this process and provide real time analysis infrequency domain OCT, signal data may be analyzed prior to performing anFFT. Other technologies can be used to determine that the user has someeye movement.

If no fixation problem has been detected, the scan control and analysismodule 824 completes the scan of the user's eyes, stores the imageand/or scan data in the images/scans database 826, and analyzes theA-scan data at block 915 to generate/determine a risk assessment and/ordiagnosis at block 916 by accessing the data and/or algorithms stored inthe disease risk assessment/diagnosis database 808. In some embodiments,groups of A-scans, partial or full B scans, or partial or full 3D-OCTdata can be analyzed.

As used herein the term “nomogram” generally refers to predictive tools,algorithms, and/or data sets. Nomograms in general can providepredictions for a user based on the comparison of characteristics of theuser with the nomogram. The nomograms are derived, generated,calculated, or computed from a number, for example, hundreds, thousands,or millions of users/patients who exhibited the same condition (normalor diseased). In some embodiments described herein, nomograms comparethe risk of having a disease based on physical characteristics.Accordingly, in some cases, nomograms can provide individualizedpredictions that are relative to risk groupings of patient populationswho share similar disease characteristics. In some embodiments,nomograms can be used to provide the risk estimation or risk assessmenton a 0-100% scale. Alternatively, nomograms used herein can provide anexpected value, for example, at a certain position in the eye there isan expected eye thickness value of 100 microns.

Generally, nomograms have been developed and validated in large patientpopulations and are highly generalizable, and therefore, nomograms canprovide the objective, evidence-based, individualized risk estimation orassessment. Accordingly, nomograms can be used as described herein toempower patients and allow them to better understand their disease.Further, nomograms as used herein can assist physicians with clinicaldecision-making and to provide consistent, standardized and reliablepredictions.

In the illustrative method shown in FIG. 9 at block 917, an eye healthassessment or eye health grade report, as illustrated in FIGS. 10A and10B, is generated for the user by accessing the disease riskassessment/diagnosis database 808. At block 918, the physician referraldatabase 804 is accessed to generate a recommendation of when the usershould visit a physician (for example, within one to two weeks). Thephysician referral database 804 is also accessed to generate, compile alisting of physicians suitable for treating the patient. Suitability fortreatment could be determined by a physician-defined subspecialty areaor areas, such as retina, cornea, glaucoma, or the like. In anotherembodiment, suitability for treatment could be determined additionallyor completely by the severity of a given diagnosis. For example, somephysicians may feel comfortable treating mild diabetic retinopathy whileothers would permit referrals for severe forms of retinopathy, such asproliferative retinopathy. The physician referral list can be randomlygenerated or selected based on referral fee payments paid by physicians,insurance companies, or based on location of the physician relative tothe user's present location or office/home address, or based on the typeof detected disease, or based on the severity of the detected disease,based on the location or proximity of the system relative the locationof the physician, or based on a combination thereof. At block 919, thereport is displayed to the user by using reporting/output module 806 andoutput device 102. In certain embodiments, the report data is stored inthe user/patient database 802 for future analysis or comparativeanalysis with future scans.

In some embodiments, the main body 106 is not supported by the user 114.For example, the main body 106 may be supported by a free-standingstructure, as shown in FIG. 10A. The user 114 may look into theeyepiece(s). The user 114 may be seated on a seating apparatus, whichmay include a height-adjusting mechanism. The main body 106 maysupported by a height-adjustable support.

In some embodiments, such as those shown in FIGS. 10B-10C, a strap 1005is connected to the main body 106. The strap may function to fully orpartly support the main body 106, as shown in FIG. 10B. The strap 905may be excluded in some embodiments. The main body 106 may be hand heldby the user. In some embodiments, the main body 106 may be supported oneyewear frames. In some embodiments, all of the optics are containedwithin the main body 106 that is directly or indirectly supported by theuser 114. For example, the main body 106 in FIG. 10B may include anoptical coherence tomography system, an alignment system, and a dataacquisition device. The data acquisition device may wirelessly transmitdata to a network or computer system or may use a cable to transfercontrol signals. FIG. 10C is similar to that of FIG. 1 and is supportedby a separate support structure (for example, an zero gravity arm). Insome embodiments, a strap, belt, or other fastener assists in thealignment of the main body 106 with one or both eyes of the user 114.

In some embodiments, as shown in FIG. 10D, the user wears an object 1010connected to the eyepiece. The wearable object 1010 may include ahead-mounted object, a hat or an object to be positioned on a user'shead. As described above, in some embodiments, the main body 106 issupported on an eyewear frame worn by the user like glasses. Thewearable object 1010 may fully or partly support the main body 106and/or may assist in aligning the main body 106 with one or both eyes ofthe user 114.

Referring to FIGS. 11A and 11B, there are illustrated two exampleembodiments of the eye health grades and the eye health assessmentreports. With reference to FIG. 11A, the eye health grades report cancomprise without limitation a numeric and/or letter grade for each eyeof the user for various eye health categories, including but not limitedto macular health, optic nerve health, eye clarity, or the like. The eyehealth grades report can also comprise at least one recommendation tosee or consult a physician within a certain period of time, and canprovide at least one possible physician to contact. Data for generatingthe recommendation information and the list of referral physicians arestored in the physician referral database 804. In reference to FIG. 11B,the eye health assessment report can comprise a graphical representationfor each eye of the user for various eye health categories. The reportcan be presented to the user on an electronic display, printed on paper,printed onto a card that the user inserted into the machine,electronically stored on the user's identification card, emailed to theuser, or a combination thereof.

With reference to FIG. 12, there is illustrated another embodiment ofthe computer system 104 connected to remote system 110 andbilling/insurance reporting and payment systems 1201. The billing module810 can be configured to communicate with billing/insurance reportingpayment systems 1201 through communications medium 108 in order torequest or process an insurance claim for conducting a scan of theuser's eyes. Based on communications with billing/insurance reportingand payment system 1201, the billing module 810 can also be configuredto determine the amount payable or covered by the user's insurancecompany and/or calculate or determine the co-pay amount to be charge theconsumer. In certain embodiments, the user can interact with the userinterface module 805 to schedule an appointment with the one of therecommended physicians and/or schedule a reminder to be sent to the userto consult with a physician. The computer system 104 or a remote system110 can be configured to send the user the reminder via email, textmessage, regular mail, automated telephone message, or the like.

Computing System

In some embodiments, the systems, computer clients and/or serversdescribed above take the form of a computing system 1300 shown in FIG.13, which is a block diagram of one embodiment of a computing system(which can be a fixed system or mobile device) that is in communicationwith one or more computing systems 1310 and/or one or more data sources1315 via one or more networks 1310. The computing system 1300 may beused to implement one or more of the systems and methods describedherein. In addition, in one embodiment, the computing system 1300 may beconfigured to process image files. While FIG. 13 illustrates oneembodiment of a computing system 1300, it is recognized that thefunctionality provided for in the components and modules of computingsystem 1300 may be combined into fewer components and modules or furtherseparated into additional components and modules.

Client/Server Module

In one embodiment, the system 1300 comprises an image processing andanalysis module 1306 that carries out the functions, methods, and/orprocesses described herein. The image processing and analysis module1306 may be executed on the computing system 1300 by a centralprocessing unit 1304 discussed further below.

Computing System Components

In one embodiment, the processes, systems, and methods illustrated abovemay be embodied in part or in whole in software that is running on acomputing device. The functionality provided for in the components andmodules of the computing device may comprise one or more componentsand/or modules. For example, the computing device may comprise multiplecentral processing units (CPUs) and a mass storage device, such as maybe implemented in an array of servers.

In general, the word “module,” as used herein, refers to logic embodiedin hardware or firmware, or to a collection of software instructions,possibly having entry and exit points, written in a programminglanguage, such as, for example, Java, C or C++, or the like. A softwaremodule may be compiled and linked into an executable program, installedin a dynamic link library, or may be written in an interpretedprogramming language such as, for example, BASIC, Perl, Lua, or Python.It will be appreciated that software modules may be callable from othermodules or from themselves, and/or may be invoked in response todetected events or interrupts. Software instructions may be embedded infirmware, such as an EPROM. It will be further appreciated that hardwaremodules may be comprised of connected logic units, such as gates andflip-flops, and/or may be comprised of programmable units, such asprogrammable gate arrays or processors. The modules described herein arepreferably implemented as software modules, but may be represented inhardware or firmware. Generally, the modules described herein refer tological modules that may be combined with other modules or divided intosub-modules despite their physical organization or storage.

In one embodiment, the computing system 1300 also comprises a mainframecomputer suitable for controlling and/or communicating with largedatabases, performing high volume transaction processing, and generatingreports from large databases. The computing system 1300 also comprises acentral processing unit (“CPU”) 1304, which may comprise amicroprocessor. The computing system 1300 further comprises a memory1305, such as random access memory (“RAM”) for temporary storage ofinformation and/or a read only memory (“ROM”) for permanent storage ofinformation, and a mass storage device 1301, such as a hard drive,diskette, or optical media storage device. Typically, the modules of thecomputing system 1300 are connected to the computer using a standardsbased bus system. In different embodiments, the standards based bussystem could be Peripheral Component Interconnect (PCI), Microchannel,SCSI, Industrial Standard Architecture (ISA) and Extended ISA (EISA)architectures, for example.

The example computing system 1300 comprises one or more commonlyavailable input/output (I/O) devices and interfaces 1303, such as akeyboard, mouse, touchpad, and printer. In one embodiment, the I/Odevices and interfaces 1303 comprise one or more display devices, suchas a monitor, that allows the visual presentation of data to a user.More particularly, a display device provides for the presentation ofGUIs, application software data, and multimedia presentations, forexample. In the embodiment of FIG. 13, the I/O devices and interfaces1303 also provide a communications interface to various externaldevices. The computing system 1300 may also comprise one or moremultimedia devices 1302, such as speakers, video cards, graphicsaccelerators, and microphones, for example.

Computing System Device/Operating System

The computing system 1300 may run on a variety of computing devices,such as, for example, a server, a Windows server, a Structure QueryLanguage server, a Unix server, a personal computer, a mainframecomputer, a laptop computer, a cell phone, a personal digital assistant,a kiosk, an audio player, and so forth. The computing system 1300 isgenerally controlled and coordinated by operating system software, suchas z/OS, Windows 95, Windows 98, Windows NT, Windows 2000, Windows XP,Windows Vista, Linux, BSD, SunOS, Solaris, or other compatible operatingsystems. In Macintosh systems, the operating system may be any availableoperating system, such as MAC OS X. In various embodiments, thecomputing system 1300 may be controlled by a proprietary operatingsystem. Conventional operating systems control and schedule computerprocesses for execution, perform memory management, provide file system,networking, and I/O services, and provide a user interface, such as agraphical user interface (“GUI”), among other things.

Network

In the embodiment of FIG. 13, the computing system 1300 is coupled to anetwork 1310, such as a modem system using POTS/PSTN (plain oldtelephone service/public switched telephone network), ISDN, FDDI, LAN,WAN, or the Internet, for example, via a wired, wireless, or combinationof wired and wireless, communication link 1315. The network 1310communicates (for example, constantly, intermittently, periodically)with various computing devices and/or other electronic devices via wiredor wireless communication links. In the example embodiment of FIG. 13,the network 1310 is communicating with one or more computing systems1317 and/or one or more data sources 1319.

Access to the image processing and analysis module 1306 of the computersystem 1300 by remote computing systems 1317 and/or by data sources 1319may be through a web-enabled user access point such as the computingsystems' 1317 or data source's 1319 personal computer, cellular phone,laptop, or other device capable of connecting to the network 1310. Sucha device may have a browser module implemented as a module that usestext, graphics, audio, video, and other media to present data and toallow interaction with data via the network 1310.

The browser module or other output module may be implemented as acombination of an all points addressable display such as a cathode-raytube (CRT), a liquid crystal display (LCD), a plasma display, or othertypes and/or combinations of displays. In addition, the browser moduleor other output module may be implemented to communicate with inputdevices 1303 and may also comprise software with the appropriateinterfaces which allow a user to access data through the use of stylizedscreen elements such as, for example, menus, windows, dialog boxes,toolbars, and controls (for example, radio buttons, check boxes, slidingscales, and so forth). Furthermore, the browser module or other outputmodule may communicate with a set of input and output devices to receivesignals from the user.

The input device(s) may comprise a keyboard, roller ball, pen andstylus, mouse, trackball, voice and/or speech recognition system, orpre-designated switches or buttons. The output device(s) may comprise aspeaker, a display screen, a printer, or a voice synthesizer. Inaddition a touch screen may act as a hybrid input/output device. Inanother embodiment, a user may interact with the system more directlysuch as through a system terminal connected to the score generatorwithout communications over the Internet, a WAN, or LAN, or similarnetwork.

In some embodiments, the system 1300 may comprise a physical or logicalconnection established between a remote microprocessor and a mainframehost computer for the express purpose of uploading, downloading, orviewing interactive data and databases on-line in real time. The remotemicroprocessor may be operated by an entity operating the computersystem 1300, including the client server systems or the main serversystem, and/or may be operated by one or more of the data sources 1319and/or one or more of the computing systems. In some embodiments,terminal emulation software may be used on the microprocessor forparticipating in the micro-mainframe link.

In some embodiments, computing systems 1317 that are internal to anentity operating the computer system 1300 may access the imageprocessing and analysis module 1306 internally as an application orprocess run by the CPU 1304.

User Access Point

In one embodiment, a user access point comprises a personal computer, alaptop computer, a cellular phone, a GPS system, a Blackberry® device, aportable computing device, a server, a computer workstation, a localarea network of individual computers, an interactive kiosk, a personaldigital assistant, an interactive wireless communications device, ahandheld computer, an embedded computing device, or the like.

Other Systems

In addition to the systems that are illustrated in FIG. 13, the network1310 may communicate with other data sources or other computing devices.The computing system 1300 may also comprise one or more internal and/orexternal data sources. In some embodiments, one or more of the datarepositories and the data sources may be implemented using a relationaldatabase, such as DB2, Sybase, Oracle, CodeBase and Microsoft® SQLServer as well as other types of databases such as, for example, a flatfile database, an entity-relationship database, and object-orienteddatabase, and/or a record-based database.

With reference to FIG. 14A, there is illustrated an example method fordetermining or generating a risk assessment of a disease, such as an eyedisease, thereby allowing the generation of a health grade andrecommended time to see a physician. The example shown in FIG. 14A isfor retinal disease, however, the process and method illustrated can beused for other diseases or eye diseases. For example, by focusing theoptical coherence tomography system at different antero-posteriorlocations using the power optics 210, A-scan, B-scan, or 3D-OCT scandata can be collected for any of the structures of the eye that liealong the central axis, such as, for example, the pre-cornea, cornea,anterior chamber, iris, crystalline lens, intraocular lens implant,vitreous body, retina, retinal pigment epithelium, choriocapillaris,choroid, optic nerve, or lamina cribrosa. In this example, the scancontrol and analysis module 824 is configured to determine the thicknessof the retina based on the A-scan data derived from the main body 106.This data may include but is not limited to A-scan data from differentA-scans. The scan control and analysis module 824 can also be configuredto access data and algorithms in the disease risk assessment/diagnosisdatabase 808 to calculate the risk assessment of retinal disease basedon the measured thickness of the retina as illustrated by the functioncurve in FIG. 14A. The reporting/output module 806 can be configured tonormalize the calculated risk assessment value into an eye health letteror numerical grade or score. The reporting/output module 806 can also beconfigured to access data and algorithms in the physician referraldatabase 804 to calculate a recommended time to see a physician based onthe calculated risk assessment value.

With reference to FIG. 14B, there is illustrated another example methodor process for determining or generating a risk assessment of disease bycomparing the scan data to the disease risk assessment/diagnosisdatabase 808 comprising, for example, minimum and maximum thickness dataand algorithms, and such minimum and maximum thickness data andalgorithms that can be based on or are in the form of nomograms. Incertain embodiments, the system is configured to generate scan data forportions of the eye scanned to determine thickness of the retina at anyone point, and compare such data to histograms and/or nomograms (forexample, nomograms that show expected thickness at said locationlikelihood of or disease for a given thickness) to derive a riskassessment. The system can also be configured to generate an averagethickness for the entire retina that is scanned, and compare such datato histograms and/or nomograms to derive a risk assessment.

The term “histogram” as used herein generally refers to an algorithm,curve, or data or other representation of a frequency distribution for aparticular variable, for example, retinal thickness. In some cases, thevariable is divided into ranges, interval classes, and/or points on agraph (along the X-axis) for which the frequency of occurrence isrepresented by a rectangular column or location of points; the height ofthe column and/or point along the Y-axis is proportional to or otherwiseindicative of the frequency of observations within the range orinterval. “Histograms,” as referred to herein, can comprise measureddata obtained, for example, from scanning the eyes of a user, or cancomprise data obtained from a population of people. Histograms of theformer case can be analyzed to determine the mean, minimum, or maximumvalues, and analyze changes in slope or detect shapes or curvatures ofthe histogram curve. Histograms of the latter case can be used todetermine the frequency of observation of a measured value in a surveyedsample.

In the instance where an average thickness value is derived from thescan data, there are some conditions/diseases that may be indicated bythickening of the retina in a localized area. Accordingly, such acondition may not significantly affect the average thickness value (forexample, if a substantial portion of the retina is of normal thickness).Therefore, the maximum thickness value may be needed to detect thisabnormal thickening in the retina. In some embodiments, this maximumthickness value may be due to a segmentation error. Accordingly, a morestable way of determining the maximum value may also be to use the valuecorresponding to 95% (or any value between 75% and 99%) maximalthickness. The foregoing can also be applied to minimum retinalthickness or any other value, measurement, and/or detectable conditionin the eye. For example, with minimum retinal thickness, if the user hasa macular hole, there will only be a small area of zero thickness, andpossibly not enough to significantly reduce the average thickness, butdefinitely an abnormality that may be detected.

In various embodiments, the system may be configured to createhistograms of measured thickness and/or measured intensity values and/orslopes or derivatives of intensity values and/or variables to identifyabnormalities. For example, changes or substantial changes in slope(calculated as the derivative of adjacent intensity values) may indicatehyporeflective or hyperreflective structures that may not affect mean oraverage intensity values, but may be indicative of disease orconditions. For example, the system can determine if the distribution ofretinal thicknesses across the measured portion of the retina matchesthat of the normal population. Deviation from such a “normal” histogramwould result in lower health grades/higher risk assessments.

In various embodiments, the methods or processes described herein can beused to determine or generate a risk assessment of maculopathy based,for example, on abnormal thickening of the retina or fovea, the presenceof hyperreflective (bright or high intensity) or hyporeflective (dark orlow intensity) structures in the outer half of the retina, the presenceof hyporeflective (dark) structures in the inner half of the retina, thepresence of irregularities in the contour of the retinal pigmentepithelium that depart from the normal curvature of the eye, or of thepresence of hypertransmission of light through the retinal pigmentepithelium when compared to a database of normal values stored in thedisease risk assessment/diagnosis database 708.

As described above, there are several ways to detect or generate a riskassessment for several diseases or conditions. In certain embodiments,scan data is compared to data found in normal people to identifysimilarities or differences from a nomogram and/or histogram. In variousembodiments, scan data is compared to data found in people with diseasesto identify similarities or differences from nomograms and/orhistograms. The pathognomonic disease features could be indicated bysimilarity to nomograms, for example, images, histograms, or other data,etc. from diseased patients.

In one embodiment, “normal” data (for example, histograms) are createdfor retinal thickness in each region of the retina (optic nerve, fovea,temporal retina) and compare to measured, detected, scanned, orencountered values to these “normal” data (for example, histograms) todetermine relative risks of retinal disease or other diseases. The samecan be performed for nerve fiber layer (NFL) thickness to detectglaucoma. In various embodiments, the detection or generation of a riskassessment for glaucoma is performed or generated by analyzing collinearA-scan data to see if curvilinear thinning indicates the presence ofglaucoma because glaucoma tends to thin the NFL in curvilinear bundles.The NFL radiates out from the optic nerve in a curvilinear fashion likeiron filings around a magnet. Measuring and analyzing a sequence ofA-scan data that follow such a curvilinear path may be useful toidentify such thinning that is characteristic of glaucoma. The analysiscould be centered on and/or around the optic nerve or centered on and/oraround the fovea or elsewhere. In another embodiment, the detectionand/or generation of a risk assessment for glaucoma is performed orgenerated by analyzing the inner surface of the optic nerve to determinethe optic disc cup volume.

The system can also be configured to detect and/or generate a riskassessment for optical clarity wherein the system integrates A-scan datain the Z direction and compares some or all the A-scan data to anomogram value or values, or, for example, a histogram. In general,darker A-scans will probably indicate the presence of media opacities,for example, cataracts, that decrease optical clarity (therefore,increase the subject's risk of having an optical clarity problem, forexample, cataracts). In various embodiments, OCT data, either in theform of A-scans, B-scans or 3D-OCT scans, can be collected of thecornea, anterior chamber, iris, and lens to directly detectabnormalities, such as, for example, cataracts or corneal scars, thatmay interfere with optical clarity. Nomograms of intensity valuesnormally encountered in these structures could be used for determinationof abnormal intensity values. Alternatively, a database of featuresencountered with specific diseases can be referenced to determine iffeatures consistent with that disease are present.

The system can also be configured to detect or generate risk assessmentsfor retinal pigment epithelium (RPE) features that depart from thenormal curvature of the eye (drusen, retinal pigment epithelialdetachments). Such RPE features can be detected by fitting the detectedRPE layer to a polynomial curve that mimics the expected curvature forthe eye, and using a computer algorithm to analyze, compare, or examinethe difference between these curves. For example with respect to FIG.15, the system can be configured to subtract the polynomial curve thatmimics the expected curvature of the RPE layer 1502 from the detectedRPE layer curve 1504, and analyze and/or compare the resultingdifference/value 1506 with the values (for example, in a histogram ornomogram) from normal and/or diseased eyes to generate a diagnosis orrisk assessment. The foregoing method and process is similar to ameasure of tortuosity in that a bumpy RPE detection will generally havemore deviations from a polynomial curve than smooth RPE detections,which are common in young, healthy people.

Such RPE detection can also be used to detect increased transmissionthrough the RPE which is essentially synonymous with RPE degeneration oratrophy. In certain embodiments, the system is configured to analyze thetissue layer beyond or beneath the RPE layer. Using imaging segmentationtechniques, the RPE layer can be segmented. In certain embodiments, thesystem is configured to add up all of the intensity values beneath theRPE detection. When atrophy is present, there are generally many highvalues beneath the RPE line, which makes the integral value high andwould increase the patient's risk of having a serious macular condition,such as geographic atrophy.

With reference to FIG. 16, the system can also be used to detect orgenerate risk factors for abnormal intensities within the retina. Incertain embodiments, the system is configured to divide the retina intoan inner 1602 and outer 1604 half based on the midpoint between theinternal limiting membrane (ILM) detection 1606 and the RPE detectionlines 1608. In some instances, a blur filter (for example, a Gaussianblur, radial blur, or the like) is applied to the retinal tissue toremove speckle noise and/or other noise. For each the inner and outerretina regions, a first derivative of the intensity values (with respectto position, for example, d/dx, d/dy, or the like) can be calculated todetermine the slope of the curve to differentiate the areas where thereare large changes from dark to bright or vice versa across lateraldimensions of the tissue. For example, intensities or derivatives withinthe retina can be compared to, for example, normal histograms, whereininner retinal hypointensity can be an indicator of cystoid macularedema; or wherein outer retinal hypointensity can be an indicator ofcystoid macular edema, subretinal fluid, or diffuse macular edema; orwherein outer retinal hyperintensity can be an indication of diabetes(which may be the cause of diabetic retinopathy, or damage to the retinadue to, for example, complications of diabetes mellitus), or age-relatedmacular degeneration.

Data from normal patients can used to compile histograms of intensityand/or slope (derivative) data to indicate expected values for normalpeople. Data from people with various diseases can also be placed intohistograms of intensity and/or derivative (slope) values to indicateexpected values for those people with diseases. In certain embodiments,a relative risk will then be developed for each entry on the histogramsuch that this risk can be applied to unknown cases. For example, insome instances, people with 10% of their outer retinal intensity valuesequal to 0 have an 85% chance of having a retinal problem. Accordingly,such users may receive a health grade of 15. In another example, peoplewith any inner retinal points less than 10 have a 100% chance ofdisease, and therefore such users may receive a health grade of 5.

Alternatively, as discussed herein, the foregoing method or process canalso be used to determine or generate a risk assessment of glaucomabased on patterns of thinning of the macular and/or peripapillary nervefiber layer or enlarged cupping of the optic nerve head as compared to adatabase of normal and abnormal values stored in the disease riskassessment/diagnosis database 708. Similarly, to detect or develop arisk assessment for uveitis, a histogram of expected intensity valuesabove the inner retinal surface (in the vitreous), for example, can beused. The presence of large, bright specks (for example, high intensityareas) in the vitreous cavity would indicate possible uveitis and wouldlikely indicate a need for referral. The foregoing method and processcan also be used to determine or generate a risk of eye disease based onthe intensity levels of the image signal as compared to a database ofnormal and abnormal values stored in the disease riskassessment/diagnosis database 708.

In various embodiments, the foregoing method and process can also beused to determine or generate a risk assessment of uveitis based onhyperreflective features in the anterior chamber or vitreous cavity ascompared to normal and abnormal hyperreflective features stored in thedisease risk assessment/diagnosis database 708. The foregoing method canalso be used to detect so-called ‘tobacco dust,’ pigment clumps, orgranules posterior to the lens that can indicate the presence of aperipheral retinal tear allowing liberation of retinal pigmentepithelial pigment. The foregoing method and process can also be used todetermine or generate a risk assessment of anterior eye disease based ondetection of pathognomonic disease features, such as cystoid retinaldegeneration, outer retinal edema, subretinal fluid, subretinal tissue,macular holes, drusen, retinal pigment epithelial detachments, and/orretinal pigment epithelial atrophy, wherein the detected features arecompared with such pathognomonic disease features stored in the diseaserisk assessment/diagnosis database 708. In certain embodiments, thesystem is configured to perform template matching wherein the systemdetects, compares, and/or matches characteristics from A-scans generatedfrom scanning a user, also known as unknown A-scans, with a database ofpatterns known to be associated with disease features, such assubretinal fluid, or the like.

With reference to FIGS. 1, 8 and 9, the optical coherence tomographysystem 100 is configured to allow the user to self-administer an OCTscan of the user's eyes without dilation of the eyes, and obtain a riskassessment or diagnosis of various diseases and ailments without theengaging or involving a doctor and/or technician to align the user'seyes with the system, administer the OCT scan and/or interpret the datafrom the scan to generate or determine a risk assessment or diagnosis.In one embodiment, the optical coherence tomography system 100 canperform a screening in less than two minutes, between 2-3 minutes, or2-5 minutes. In certain embodiments, the use of the binocular systemallows the user to self-align the optical coherence tomography system100. The optical coherence system 100 with a binocular system is fastersince it scans both eyes without repositioning and can allow the opticalcoherence tomography system 100 to scan a person's bad eye because theperson's bad eye will follow the person's good eye as the latter tracksthe fixation marker. Accordingly, the optical coherence tomographysystem 100 reduces the expense of conducting an OCT scan, thereby makingOCT scanning more accessible to more people and/or users, and savingmillions of people from losing their eye sight due to eye diseases orailments that are preventable through earlier detection. In oneembodiment, the optical coherence tomography system 100 is configured tohave a small-foot print and/or to be portable, such that the opticalcoherence tomography system 100 can be installed or placed in drugstores, retail malls or stores, medical imaging facilities, grocerystores, libraries, and/or mobile vehicles, buses, or vans, a generalpractitioner's or other doctor's office, such that the optical coherencetomography system 100 can be used by people who do not have access to adoctor. In another embodiment, the optical coherence tomography system100 is configured to be a hand-held device, and/or can be powered by anexternal power source and/or bidirectional communications with acomputer system, such as, for example, a desktop computer, laptopcomputer, and/or other computer system.

Additional features may be added to the optical coherence tomographysystem 100. In some instances, the additional features may enhanceperformance of the system 100.

FIGS. 17A-C show B-scans obtained when the OCT system is positioned toofar anterior, at a position that provides increased field of view, ortoo far posterior with respect to the eye. As shown, when the OCT systemis too far anterior or too far posterior with respect to the eye thefield of view (here the size or width of the B-scan) is reduced.

FIGS. 18A-C further show how a field of view of the system 100 can beaffected by the location of the OCT system with respect to the eye.FIGS. 18A-C each show two probe beams 2005 a and 2005 b emitted from anoptical coherence tomography system along different trajectories, asshown, by, for example, rotating a galvanometer 280 to probe differentportions of the retina. For example, rotation of the galvanometer 280may cause light to be emitted along different trajectories as describedabove. The trajectories may intersect with each other at rotation point2010. Movement, for example, rotation, of the galvanometer 280, maycause the trajectory of the probe beam 2005 to rotate about the rotationpoint 2010. Typically, a plurality of beams 2005 will be emitted by thesystem, such that the eye tissue can be sufficiently imaged. Thus, insome embodiments, numerous other beams are emitted between beams 2005 aand 2005 b. The beams are shown to intersect with each other at arotation point or common point 2010. In some embodiments, the locationof this point may coincide with a focus of the beams. Each of the beams2005 a and 2005 b and the beams therebetween (not shown) can causestructures of the eye to reflect light, such that A-scan data can bebeams associated with each beam. FIGS. 18A-C show a region 2015 that canbe imaged by the plurality of beams. Thus, the emitted light may sweepacross a swath of points of the retina. The position of the rotationpoint 2010 may influence the lateral dimension (for example, length orwidth) of this region 2015. The region 2015 may be described as a fieldof view and may be correlated with the amount of data within a B-scan orset of A-scans that is above a threshold intensity.

In FIG. 18A, the rotation point 2010 is located behind/posterior to thepupil 2030. Light beams 2020 a and 2020 b incident at high incidentangles will therefore be unable to enter the eye, as they will beblocked by the iris 2025. The angle of incidence and therefore theregion 2015 of the eye that can be imaged are limited in this situation.

In FIG. 18B, the rotation point 2010 is located at a pupil plane at thepupil 2030 (for example, in the plane of the pupil). Because the lightbeams intersect at the rotation point 2010, no incident light will beblocked by the iris 2025. Therefore, the region 2015 of the eye that canbe imaged is not limited to obstruction by the iris as shown. A largerfield of view is thereby provided.

In FIG. 18C, the rotation point 2010 is located in front of/anterior tothe pupil 2030. As in FIG. 18A, light beams 2020 a and 2020 b incidentat high incident angles will therefore be unable to enter the eye, asthe will be blocked by the iris 2025. The angle of incidence andtherefore the region 2015 of the eye that can be imaged are limited inthis situation. Accordingly, the regions 2015 probed in FIGS. 18A and18C are shown reduced in comparison to the region 2015 probed in FIG.18B.

Referring again to FIGS. 17A-C, examples of how B-scans can be affectedby the position of one or more movable components are shown. When therotation point 2010 is too far anterior (FIG. 17A) or too far posterior(FIG. 17C), less tissue is imaged than if the rotation point 2010 ispositioned at a more optimal position (FIG. 17B). In each case, lightfrom the center of the eye is reflected back towards the OCT system.However, when the rotation point 2010 is at a non-optimal location,light from the more extreme positions of the eye is not reflected backtowards the OCT system. It is theorized that this light is insteadscattered by the iris before it ever enters the eye, as illustrated inFIGS. 18A-C. By analyzing the resultant B-scans obtained for differentpositions of one or more movable components, it may thus be possible todetermine a position that improves the field of view and thus theimaging capabilities of the OCT system. A risk assessment or diagnosismay then (for example, automatically) be performed by the OCT systemusing an improved field of view, the improved field of view beingobtained when the movable components are in a first position, and theimproved field of view being larger than a field of view obtained fromwhen the movable components are in a different second position.

Accordingly, it can be advantageous in some embodiments to position theintersection/rotation point 2010 at a specific location of the eye to,for example, improve the field of view and/or to reduce obstruction ofincident light by the iris 2025. The location may comprise, for example,a position in or near the pupil of the user eye, a location in a planeof the iris of the user eye, a location within the lens of the user eye,or a location posterior to the pupil of the user eye. Other locationsare possible. Additionally, certain embodiments may not include awell-defined intersection/rotation point 2010 at all. In someembodiments, OCT system 100 is configured to adjust ananterior-posterior distance of the OCT system with respect to the eye ora working distance of the OCT system. FIG. 19 shows at least one movableoptical component (for example, lens 205) of the optical coherencetomography system 100. The position of the at least one movable opticalcomponent can at least partly determine the position of the rotationpoint 2010 and the working distance of the OCT system. In certainembodiments, for example, the working distance may at least partlydetermine the position of the rotation point 2010. The working distance2035 may be measured, for example, as the distance between the outermostlens or window of the eyepiece and the rotation point 2010 or a positionof the eyecup 120 and the rotation point 2010. (Other referencelocations on the OCT system 100 can be used.) Thus, increasing theworking distance can move the rotation point 2010 further anterior. Insome embodiments, the OCT system may be moved with respect to the eye.As changing either the position of the at least one movable component,the working distance of the OCT system 100, or of the OCT system itselfcan change the position of the rotation point 2010 with respect to theeye, these changes may affect an angular field of view of the retina3010, for reasons described above in relation to FIGS. 18A-C.

As described above, it may be desirable to position the intersectionpoint or rotation point 2010, or another region of the emitted probebeam in order to reduce such blocking. In one instance, a field of view(a size of a set of A-scans, a B-scan or a region of the eye that can beimaged) is monitored as the galvanometer 280 is rotated. A moveable oradjustable optical component, such as one or more of the lens 205,adjustable optics 210, eyecup 120, and the eyepiece 203, may be moved toadjust a working distance, the location of the eyepiece 203 and/or OCTsystem 100 (in whole or part) with respect to the eye, which may atleast partly control the field of view. The adjustment may change arotation point to, for example, position the rotation point in or nearthe plane of the pupil. The adjustment may allow more light (forexample, a wider range of probe beam trajectories) to enter the eye fromthe system than would otherwise occur, thereby increasing a field ofview. For example, the adjustment may increase the number of probe beamorientations that can enter the eye across a B-scan by reducing thelight blocked by one or more structures of the eye (for example, theiris).

Translation stages and other actuators or movement devices may beemployed to position the eye or the optics of the OCT system in theanterior-posterior direction or otherwise adjusted to provide movementin a longitudinal direction along the optical axis of the OCTinstrument. Thus, the position (for example, longitudinally along theoptical axis of the OCT instrument) of the movable component maydetermine the anterior-posterior position of the rotation point.

In certain embodiments, a translation stage such as a stage configuredto move laterally (for example horizontally) may be included. Such atranslation stage or actuator may determine the horizontal position ofthe rotation point. For example, if the stage was positioned too farmedial or lateral, the iris may block a portion of the light fromentering the eye that would be used to form a medial or lateral portionof, for example, a B-scan. In some instances, the iris may block amedial portion of the scan if the stage is too far medial, while inothers, it may block a lateral portion. Accordingly, the field of view(for example, B-scans) for the left and right eye can be compared. Ifone is smaller than the other, the translation stage for the eye withthe smaller field of view can be adjusted to increase the field of viewof that eye.

Accordingly, in some instances, a B-scan or other OCT measurement may beanalyzed or a plurality of scans or measurements are compared todetermine whether a lateral (for example, horizontal) movement of thestage or actuator is advantageous. The stage or actuator may be adjustedfor example after a user-conducted interpupillary distance alignmentprocess using for example a fixation target, such as that describedabove. Additional alignment may be performed subsequent to adjustment ofthe stage or actuator which may affect interpupillary distance.Moreover, movement of the stage or actuator may affect the position ofthe rotation point or the portion of the sample being imaged andadditional modifications of the positions of the system components maybe made to account for this effect. In various embodiments, movement ofthe stage may move one or more of the components of the OCT system. Forexample, in certain embodiments, the stage may support lens 205,adjustable optics 210, beam splitter 230 and/or mirror 260. One suchstage may be included for each of the eyes. In some embodiments, thecomponents supported by the stage are those such that stage movementdoes not affect the angle at which the beam is output from the device.In some instances, one or more movements or adjustments (for example, ofa horizontal stage) may be asymmetric across the two eyes, such that amovement associated with one eye is unparalleled or is different than amovement associated with the other eye.

In order to determine an appropriate adjustment, the one or more of themovable or adjustable optical components may be positioned (for example,systematically) in a plurality of positions, and data (for example,optical coherence data) may be obtained at these positions. The one ormore movable/adjustable optical components may then be adjusted to bepositioned at a desired position, the desired position being based on acomparison the optical coherence data obtained at each of the positions.The image data, for example, B-scan, may be obtained at the desiredposition.

In one instance, one or more sets of A-scans or one or more B-scans areanalyzed to determine a position of one or more movable/adjustablecomponents. Each of the B-scans or the sets of A-scans can be associatedwith a distinct position/setting of the one or more movable/adjustablecomponents. A property of the scans (for example, an image qualitymeasure or signal intensity value) may be compared across the B-scans orsets of A-scans in order to, for example, determine a preferred positionor setting of the one or more movable/adjustable components. In oneinstance, the sum total of the integrated intensities across the B-scansor sets of A-scans are compared. In another instance, the intensities(for example sum total of integrated intensities) at a particular pointor location within the A-scans comprising a B-scan or set of A-scans isused in the comparison. For example, a variable may be defined as thesum of the intensity at the approximate location of the retina acrossall A-scans within a B-scan or set of A-scans. This variable may then becompared across sets of A-scans or B-scans. A resultant position/settingof the one or more movable/adjustable components may be defined as theposition/setting with a set of A-scans or a B-scan having a value forthe variable that is above a threshold or is maximum (for example,greatest total intensity). Other values may be measured, calculated orconsidered and other approaches may be used to determine the desiredposition/setting and thereby increase the field of view.

In some instances, a plurality (for example, a predetermined number) ofB-scans or sets of A-scans are obtained and a preferred position/settingof the one or more movable/adjustable components is determined as aposition/setting associated with one of the B-scans or sets of A-scans.In another instance, the data is used to predict a preferredposition/setting that may or may not be a position/setting associatedwith the collected data. For example, extrapolation or interpolation maybe employed. In some instances, the B-scan or A-scan set data isdynamically collected. For example, if a shift of the one or moremovable components along an axis from a first position to a secondposition caused a preferable change in a variable, then subsequentmovements may avoid drastic changes in the opposite direction. Inanother example, the one or more movable components may repeatedly beadjusted until a variable crosses a threshold. Other approaches andmethods may be used.

It may be desirable to position or set the one or more movable oradjustable components such that a rotation point of the probe beamsemitted from the optical coherence tomography system are at or close tothe pupil plane. If the probe beams are rotated around a position not atthe pupil plane but instead shifted longitudinally towards the retina,then some of the light emitted from the optical coherence tomographysystem may be blocked by, for example, the iris before reaching thefocal point. If the probe beam is rotated around a position not at thepupil but instead shifted towards the cornea, then some of the lightemitted from the optical coherence tomography system may be blocked by,for example, the iris after reaching the focal point but before reachingother ocular structures such as the retina. By rotating light beamsemitted by the OCT system around a point at the pupil, ocularstructures, such as the iris, which surround the pupil might not blockinput light. Thus, rotating the probe beams at the pupil may increase ormaximize the amount of tissue that may be imaged by the instrument.

In some instances, a position of the retina is determined for aplurality of B-scans or sets of A-scans, each associated with adifferent position or setting of the one or more movable or adjustablecomponents. The position of the retina may then be used to predict theposition of the pupil, and the movable/adjustable components may bepositioned/set such that a rotation point is at or near the predictedpupil position. In some instances, a position of a structure of the eye,such as the cornea, iris, retina, vitreous, anterior chamber, or tearfilm interface, or from another anatomical feature, such as the orbitalrim, nasal bridge, cheekbone (maxilla), frontal bone, eyelid or skinsurface, is determined and the movable/adjustable components arepositioned/set based on the determined location. The determined locationmay be used to predict a location of another structure, such as that ofthe pupil.

In some instances, a desired position or setting of the one or moremovable or adjustable components is not based on optical coherencetomography data obtained for a specific patient. For example, theposition or setting may be selected based on normative data which maycomprise, for example, a normative position or setting that isdetermined based on population-based measurements or data. For example,for each of a plurality of patients, field of view measurements may bemade for each of a plurality of positions or settings of the one or moremovable/adjustable components. In a first instance, a preferred positionor setting is determined for each patient. A normative position/settingmay be, for example, a mean, median, or mode of the preferredpositions/setting across patients. In a second instance, themeasurements are compared to a threshold for all patients. The normativeposition or setting may then be determined as a position or setting forwhich, for example, the measurements exceeded this threshold across themost patients. In some embodiments, the movable or adjustable componentsare fixed at a normative position or setting. The movable/adjustablecomponent may be fixed in the same system or in different systems at theposition or setting determined based on normative data. Thisposition/setting may be used as the selected position/setting or may beused as a starting point for measuring different fields of view fordifferent positions/settings as described above to determine theposition/setting having an increased field of view.

In some embodiments, the normative position/setting is not determinedbased on optical coherence tomography data but is instead based onanatomical data otherwise obtained. For example, the normative positionmay be determined based on an average distance between a pupil and aretina, an average anterior-posterior distance between an eye socket anda pupil, an average anterior-posterior distance between the cornea andthe pupil, or an average anterior-posterior distance between a chin anda pupil. The normative position/setting may be separately determined fordifferent patient groups. For example, the normative position/settingmay be based on a person's age, gender or race.

In some instances, the position/setting of the one or moremovable/adjustable components may be based at least partly on sensordata. For example, a sensor may detect a position of the patient or apatient feature (for example, an eye, a cornea, a pupil, an iris, alens, a chin, an eye socket), and this position may be used to determinethe position or setting of the eyepiece 203 or OCT system 100. In oneinstance, the detected position is used to predict the position of thepupil, which is used to determine the position of the one or moremovable components.

Accordingly, in some embodiments, an optical coherence tomography system(for example, that of FIG. 1 or 3) comprises a sensor or tracker. Thesensor or tracker may determine a position of the user, one or two eyesof the user, and/or one or more structures (for example, a retina,pupil, cornea, or lens) of the user's eye. In some embodiments, thesensor or tracker is positioned on or attached to main body 106, zerogravity arm 116, or even eyecup 120. In some embodiments, the sensor ortracker is a device separate from the main body 106. In someembodiments, the sensor or tracker is attached to or comprised withinthe system shown in FIG. 3.

In one instance, the sensor emits light or ultrasound from a lightsource and detects light reflected back. The light may be reflected backfrom a structure of the user's eye, such as the cornea, iris, pupil,retina, vitreous, anterior chamber, or tear film interface, or fromanother anatomical feature, such as the orbital rim, nasal bridge,cheekbone (maxilla), frontal bone, eyelid or skin surface. The sensormay determine the position of the structure based on the time differencebetween the time the light (for example, a pulse) was emitted and thetime the light was detected. In other instances, other types of sensorsor trackers may be used. For example, an optical coherence tomographyinstrument may determine the position of an eye structure based oninterference or reflectance results.

In some embodiments, the position/setting of the one or moremovable/adjustable components is based on a combination of approaches.For example, the position/setting may be determined based on non-opticalcoherence tomography sensor data and optical coherence tomography data.The position/setting may be determined based on field-of-view data andsensor data and/or a determined normative position. The position may bedetermined based on sensor data and a determined normative position. Incertain embodiments, at least one of normative data or sensor data maybe used to assist in determining a starting point for multiple OCTmeasurements that are subsequently employed to determine a position orsetting which provides a further increased field of view.

Other approaches are possible. In some embodiments, for example, anoptical coherence tomography system 100 comprises a chin rest. In suchinstances, the system 100 may be configured to automatically adjust orto allow for manual adjustment between the main body (and/or theeyepiece) and the patient's eyes. The adjustment may be fine, on theorder of about 0.5, 1, 2, 3, 4, 5, 10, 20, 30 or 50 millimeters. Theadjustment may comprise any adjustment described herein, such as anadjustment of one or more moveable optical components to, for example,improve a field of view of the system 100. In one instance, the distancebetween the main body and/or an optical component of in the main bodyand the patient's eye is systematically adjusted from a first distanceto a second distance. The chin rest may move in certain embodimentsalthough in various embodiments the chin rest may be fixed. The distancemay be based at least partly on normative values, such as an averageoffset (for example, in the anterior-posterior direction) between a chinand a pupil or an average distance between a pupil and an eyecup. Insome instances, the distance is determined based at least partly on asensor reading. For example, a sensor may detect a position of theuser's eye, pupil or iris. The sensor may comprise an optical tomographyinstrument or may comprise another optical or ultrasonic instrument. Forexample, as described above, the sensor may emit a light and determinethe time elapsed between the emission and that at which reflected light(for example, a pulse) is received. The sensor may comprise a weightsensor to sense, for example, a location of the patient's chin. A sensormay detect a position or weight of the user's chin. In certainembodiments the chin rest may move or the main body and/or eyepiece ofthe OCT system may move with respect to the chin rest and the field ofview monitored as described above to determine a suitable location ofthe eye. Other variations are possible.

In some embodiments, a position/setting of one or moremoveable/adjustable optical components can be manually adjusted by thepatient. The patient may be instructed, for example, to adjust theposition/setting based on one or more images seen by the patient. Forexample, the patient may be instructed to adjust the position until twoor more images (for example, working distance images) are aligned.Alignment may correspond to an appropriate distance of the eye to theOCT instrument. Other designs are also possible.

In some embodiments, the system 100 may be configured to screen for oneor more ophthalmic conditions. In other embodiments, the system 100 maybe configured to monitor one or more conditions. In some instances, apatient suffers from a condition that requires regular monitoring. Forexample, the condition may worsen, which may warrant differenttreatments or the condition may improve, which may warrant terminationof a treatment or follow-up. However, frequent regular appointments witha health care provider can be expensive and inconvenient. Theinconvenience and busy schedules of the health care provider and patientmay reduce the frequency of appointments to an undesirably low level,such that a health care provider is unlikely to detect changes at theirearliest stage. By having the patient use the optical coherencetomography system 100 to self administer testing and monitor thecondition, more frequent, cheaper, faster and/or more convenientmonitoring may be possible.

In certain embodiments, the system 100 can be configured to enforcestandards of care determined by a physician. For example, the system 100can be configured to be programmed to perform ophthalmic diagnostictests and other testing according to a standard of care scheduleprescribed by a physician. In certain embodiments, the system 100 can beprogrammed to operate only after a specified time interval has elapsedsince the last diagnostic test. Alternatively, the system 100 can beconfigured to notify the patient via an alarm, email, or other remindermechanism when it is time to perform another diagnostic test.

As described in greater detail below, the system 100 may be notified ofa particular condition. For example, a physician may (for example,indirectly) indicate that a patient is suffering from or at risk ofsuffering from a condition. The system 100 may be configured todetermine whether the condition is improving or worsening based onoptical coherence tomography measurements obtained by the system. Thesystem may inform a health care provider (for example, an optometrist orphysician) and/or a patient (for example, after each scan or only afterscans yielding specific results) of a monitoring result obtained by thesystem. The results may indicate whether it is advisable to see thehealth care provider. For example, the results may indicate a conditionis worsening (such that, for example, the health care provider may wishto consider alternative treatment strategies) or that the condition isimproving (such that, for example, the health care provider may wish toconsider terminating a treatment).

FIG. 20 shows a process 3000 for using an optical coherence tomographysystem for monitoring an ophthalmic condition, and FIG. 21 shows a blockdiagram of an optical coherence tomography system 3050. Lines betweencomponents of the system 3050 show connections between the components.In some embodiments, one or more of the connections are not present inthe system 3050, and in some embodiments, additional connections arepresent. The connections may be a direct physical connection, a virtualconnection, a physical network connection (for example, using atelephone line) and/or a wireless network connection. Other connectiontypes are also possible. In some instances, the system 3050 includesadditional components not shown in FIG. 21, and in some instances, thesystem 3050 does not include one or more components shown in FIG. 21.Similarly, in some instances, process 3000 does not include one or moresteps shown in FIG. 20 and/or contains additional steps. The processsteps may also be rearranged.

At step 3005 of process 3000, information related to an ophthalmiccondition may be received. Information may be received by reading a datastorage device, such as a card with a magnetic strip, a smart card or aUSB device. Information may be electronically received, wirelesslyreceived, and/or received over a network (for example, over an Internetnetwork).

Information may be received by an input device 3055 of the system 3050.The input device 3055 may comprise, for example, a receiver 3060 (forexample, a wireless receiver). The receiver 3060 may be connected to alocal or remote network, such as the Internet. While in someembodiments, the receiver 3060 receives signals from a wireless device,in others it does not. For example, the receiver 3060 may be configuredto receive a telephone line. The input device 3055 may comprise a cardreader 3065. The input device 3055 may comprise a USB drive reader 3070.In some instances, the input device receives (for example, via thereceiver 3060) information from a server 3075. For example, a physicianmay send information to the server 3075. The server may storeinformation and may then transmit the information to the input devicewhen a user is ready for a scan. For example, the user may enter anidentification code or may use a device comprising an identifier, andthe server 3075 may then send information corresponding to the user tothe input device 3055. Although one server is referred to above, one ormore servers or computers, for example, in a network, may be used. Insome instances, disease monitoring activities occur substantially on onecomputer system that holds all scan data from previous visits locally sothat comparisons to previous visits can be accomplished withoutcommunicating data across a network.

The information may identify a condition or disease. For example, theinformation may indicate that a patient is suffering from a particularcondition (for example, age-related macular degeneration, macular edema,diabetic retinopathy or glaucoma). The information may indicate a pastseverity of a condition, such as the severity of the condition at aprevious appointment. The information may indicate a thresholdindication for the condition. For example, the information may indicatethat the patient and/or a health care provider (for example, a physicianor optometrist) should be notified if the condition worsens by aspecified amount as predicted by specific measures. Thus, the system3050 may not need to screen for diseases but instead may monitorprogression of specific conditions. (However, in some embodiments, thesystem 3050 both monitors at least one condition and screens for one ormore other conditions.) In some instances, process 3000 does not includea step 3005.

At step 3010, patient information is loaded. The patient information maycomprise a history related to the ophthalmic condition. For example, thepatient information may comprise optical coherence tomographymeasurements or output related to such measurements from previous scans.The patient information may include health care provider information(for example, a name, address, e-mail and/or phone number of thepatient's physician). In some instances, the health care providerinformation and/or a patient identifier is received (for example, withthe information received at step 3005). The identifier may include, forexample, an identification number or the patient's name. The informationmay be loaded from a storage component 3080 (for example, of a local orremote computer). For example, the information may be loaded from alocal memory or may be wirelessly received from a server 3075, which mayhave the information stored on a storage component 3080. In someinstances, the information is loaded from a data storage device, such asa smart card or a credit card, which may be provided by a patient. Thus,the input device 3055 may receive the patient information. In someinstances, process 3000 does not include a step 3010.

In one embodiment, the patient inserts a card into a card reader. Thecard is encoded with a card number or code. The card number or code istransmitted to a remote location such as a server. The server canprovide information regarding condition, patient information, healthcare provider information, etc.

Though only a single storage component 3080 is shown in FIG. 21, aplurality of storage components may be present. For example, somestorage components 3080 may be physical connected to the OCT instrument3085, one or more storage components 3080 may be physically connected tothe server 3075 and one or more storage components 3080 may bephysically connected to the input device 3055. In some instances, both aremovable and a non-removable storage component 3080 are connected tothe OCT instrument 3085. Other arrangements are also possible.

At step 3015, optical coherence tomography measurements are obtained.These measurements may be any such measurements described herein. Themeasurements may be obtained by an optical coherence tomographyinstrument 3085. The optical coherence tomography instrument 3085 mayinclude components described herein, such as those associated withsystem 100. For example, the instrument 3085 may include an eyepiece203, a light source 240, an interferometer 3090, a detector 3095 and/orelectronics 3100. The eyepiece 203 can be configured to receive at leastone of the user's eyes. The light source 240 can be configured to outputlight that is directed through the eyepiece 203 into the user's eye. Theinterferometer 3090 can be configured to produce optical interferenceusing light reflected from the user's eye. The detector 3095 can bedisposed so as to detect said optical interference. The electronics 3100can be coupled to the detector 3095 and can be configured to analyzeoptical coherence tomography measurements obtained using saidinterferometer 3090 as described herein and/or can be configured todetermine an ophthalmic output related to a state of the ophthalmiccondition as described in greater detail below. The optical coherencetomography instrument 3085 may, for example, obtain A-scan, B-scan or3D-OCT data. In some instances, the type of optical coherence tomographymeasurements obtained depend on the information regarding the opticalcondition, for example, received at step 3005. For example, if a patientis suffering from narrow-angle glaucoma, the optical coherencetomography instrument 3085 may measure the depth of the anterior chamberand forego more extensive imaging of the eye. Alternatively, thisanterior chamber depth measurement may occur immediately prior toscanning of the posterior structures in the eye.

As described in greater detail above, in certain embodiments, a Z-offsetadjustment stage 290 is adjusted prior to an optical coherencetomography screening or test, thereby changing the portion of the eyethat is imaged. In some instances, one or more components of the opticalcoherence tomography instrument 3085 (for example, the Z-offsetadjustment stage 290) are moved until a posterior structure (forexample, the retina) is being imaged. During this antero-posteriormovement, optical coherence tomography data could be continuouslyacquired to produce a 3D-OCT having a total axial depth covering some orall of the antero-posterior depth of a normal eye such as 16millimeters, 22 millimeters, or 30 millimeters of distance. Thecomponents may be initially positioned to image a more anteriorstructure and may then be gradually adjusted until the posteriorstructure is being imaged. In some instances, the instrument 3085 maytherefore first scan an anterior structure and subsequently scan aposterior structure. For example, the anterior structure may be imagedduring a process of locating the posterior structure. In some instances,the posterior structure is imaged before (for example, immediatelybefore) the anterior structure.

At step 3020, an ophthalmic output is determined based on the opticalcoherence tomography measurements. In some instances, the electronics3100 of the optical coherence tomography instrument 3085 determine theophthalmic output. Notably, while—in this instance—the electronics 3100are shown to be within the optical coherence tomography instrument 3085,in some embodiments the electronics are on a remote device. For example,data from a scan may be sent to the server 3075 and electronics of theserver may analyze the data and determine the ophthalmic output. In someembodiments, the electronics can be both in the optical coherencetomography instrument 3085 and at in a remote device.

The type of output may depend on the information received in step 3005.The output may be quantitative or qualitative. For example, the outputmay include, among other things, the presence of structures such as anepiretinal membrane, macular hole, cystoid macular edema, hard exudates,neovascularization, IRMA, cotton wool spots, microaneurysms,intraretinal hemorrhages, subretinal fluid, subretinal tissue,subretinal hemorrhage, retinal pigment epithelial detachment, drusen orRPE atrophy. It may also include measurements such as the anteriorchamber depth or foveal thickness. It may include aggregatedmeasurements collected from many OCT A-scans such as the macular volume,nerve fiber layer volume, optic disc cup volume, subretinal fluidvolume, drusen volume, drusen area, and geographic atrophy area. Thesemeasurements may be based on the entire area scanned or be subsampledfrom a subset of scanned points. The output could include a count ofstructures, such as drusen or microaneurysms, or a density measure forstructures either based on their area compared to the total area scannedor based on their volume in relation to the total volume of tissuescanned. It could also be based on reflection intensities from the OCTA-scan data itself. For example, measurements of media clarity may relyon OCT signal intensities while measurements of hard exudates may relyon the distribution of intensity values for bright objects in the innerand outer retina.

The output may be based at least partly on patient information loaded instep 3010. For example, the output may compare the measurements obtainedat step 3015 to previously obtained measurements. Such a comparison mayinclude an alignment process, such as an alignment of retina mapsobtained across a plurality of scans. The comparisons may be comparisonsof aggregate values (for example, areas, volumes, sums or valuesintegrated over a region such as the retina, nerve fiber layer or opticcup or parts thereof) or point-by-point comparisons of values forexample of thicknesses or structure classifications (for example, drusenor cystoid space) across a plurality of locations in the eye. Thus,changes in sizes such as widths, areas, volumes or thicknesses may berecognized, as well as the occurrence of new structures. The previouslyobtained measurements may be stored on the storage component 3080, whichmay be comprised within the OCT instrument 3085 and/or the server 3075.The stored measurements may be associated with a date and/or time thatthe measurements were obtained or a code (such as a code associated witha card input by the user) indicating, for example, a scan number. Thus,in determining the output, the most recent scan or another referencescan may be identified and data from this scan may be loaded (ortransmitted from the server 3075) for a comparison. The comparison maythen be performed (for example, by electronics 3100). In some instances,a computer comprises the electronics 3100. Thus, the computer may beconfigured to perform a step described in embodiments herein to beperformed by the electronics 3100. For example, the computer may comparetwo or more scans, may compare a measurement to a threshold, maycalculate a percent change in a measurement, etc. The computer may becontained within the OCT instrument 3085. In some embodiments, thecomputer is connected to the OCT instrument 3085. In some embodiments,the computer is connected to the server 3075. In some embodiments theserver comprises the computer or at least part thereof. Acomputer-readable medium may also include instructions for performingsteps described herein. Accordingly, the system may comprise softwareconfigured to determine the ophthalmic output and/or to comparemeasurements to other OCT measurements (for example, measurementspreviously obtained from the patient or benchmark measurements). Thissoftware may be at a remote location such as a server. Raw image data orextracted numerical data may be transferred to the remote location suchas the server and calculations and/or comparisons performed at thatremote location. In some embodiments, data corresponding to prior testsneed not be sent to the OCT system, for example, in the case where thecomparison is made at the remote location, for example, the server. Insome embodiments, analysis is performed both at the OCT instrument andat a remote location such as the server. Accordingly, suitable softwaremay be included in at both the OCT instrument and the remote location.

The output may include a probability, such as the probability that acondition is worsening or improving. The output may include a confidencemeasure. As another example, the output may indicate that an ophthalmiccondition is worsening, improving or staying substantially the same. Theoutput may comprise an appointment request. For example, if it isdetermined that a particular change has occurred or that a threshold hasbeen crossed based on OCT data, output comprising an appointment requestmay be sent to a health care provider. The output may also comprise anindication of a recommendation for a referral or an appointment.

At step 3025, a health care provider and/or the patient are provided theophthalmic output. The ophthalmic output may be output by an outputdevice 3105, such as a transmitter 3110 (for example, a wireless networktransmitter, an electronic transmitter), a printer 3115, a phonecomponent 3120, a display 3125 and/or a fax component 3130. Theophthalmic output may be stored on a storage component 3080 (forexample, a removable storage component), such as a compact disc or a USBkey. In some instances, the storage component 3080 can be sent (directlyor indirectly, such as via the user) to a health care provider. Thenotification may comprise an output of a quantitative or qualitativeophthalmic output variable. In some instances, the notification to oneor both of the health care provider and the patient only occurs if it isprobable that the condition is worsening, if it is probable that thecondition is improving and/or if the ophthalmic output variable crossesa threshold. In some instances, the ophthalmic output itself indicatesthat a variable related to the OCT screening crossed the threshold. Thethreshold may be predefined (for example, included in the informationreceived in step 3005 or a set threshold associated with a specificophthalmic condition). For example, for a user suffering from wetage-related macular degeneration, the ophthalmic output variable maycomprise a central retinal thickness, and a threshold may be set as apreviously determined thickness plus 100 microns. The threshold andcomparison with the threshold may be made at a remote location such asat a server. If the threshold is exceeded, the health care provider maywish to consider re-treating, for example, with an anti-VEGF treatment.In another example, the ophthalmic output variable itself is anindication as to whether the threshold was crossed.

The patient may be notified of the ophthalmic output by displaying theoutput on, for example, a display 3125 such as a screen. The output mayalso be printed by a printer 3115. The output may be printed on paper oron a surface of a data storage device. For example, the patient mayinitially input a card into the system. The system may read the card toidentify information related to an ophthalmic condition or the patient.The system may then print the ophthalmic output on the surface of thecard. In some instances, the patient is instructed to return the card toa health care provide, for example, optometrist, ophthalmologist, suchthat he/she can read the printed results and/or verify that the processwas completed. Date and time information may also be printed along withthe output. In some instances, only the date and time information isprinted.

The health care provider may be provided ophthalmic output by anyappropriate process. In some embodiments, the output transmitted to thehealth care provider does not include the patient's name. Instead, thetransmission may include a patient identifier such as the code from thecard provided to the patient by the healthcare provider. Thus, thepatient's privacy may be respected in the instance that a third partywas to receive the transmission instead of the health care provider. Theoutput may be electronically sent to the health care provider (forexample, by email). In one instance, the system 3050 electronicallytransmits (for example, via a transmitter) the output to the health careprovider. The output may be printed via a printer 3115 and mailed to thehealth care provider. In one instance, the output is faxed to the healthcare provider. The output may be faxed (for example, via a fax component3130) to a health care provider. In one instance, the output is audiblysent to the health care provider. For example, the system may comprisean automated telephone component 3120, such that results are relayed viaa telephone call to the health care provider. In another example, thesystem may display, print or send the results to a person who calls thehealth care provider. In some embodiments, the output is directly sent(for example, via an output device 3105) to the health care providerfrom an instrument 3085. In other embodiments, the instrument 3085transmits the output to a server 3075 which then transmits (for example,via an output device 3105) the output to the health care provider. Instill other embodiments, data is sent from the instrument 3085 to theserver 3075, the output is determined and the output is then transmitted(for example, via an output device 3105) to the health care provider.The server may, for example, transmit the output to the health careprovider using a network. For example, the output may be provided on a(for example, password-protected) Internet site. The health careprovider may check the site regularly and/or may be sent a message (forexample, a telephonic or email message) to check the site. In someinstances, the system 3050 comprises the capability of outputting theoutput in a number of manners, such as those described herein, and ahealth care provider indicates a preferred method of receiving theoutput. The output is then transmitted to the health care provider viathis preferred method.

Accordingly, in various embodiments, the output comprises a number oftypes of outputs. For example, the output may comprise an appointmentrequest, a summary report, a single B-scan image, multiple B-scan imagesor selected B-scan images representing the disease detected by theinstrument, all of which are to be output to a health care provider, anda confirmation of the scan and a different summary report, all of whichare to be output to the user.

At step 3030, the ophthalmic data is stored. The data may be stored at astorage component 3080. The storage component 3080 may be associatedwith an OCT instrument 3085 and/or with a remote location, such as theserver 3075. In some instances, the ophthalmic data comprises rawoptical coherence tomography data. In some instances, the ophthalmicdata comprises summary data, such as an ophthalmic output disclosedherein. The stored data may be associated with the patient (for example,by using a patient identifier).

The system 3050 described herein may enable users to monitor ophthalmicconditions with fewer visits to a health care provider. Patientssuffering from conditions such as age-related macular degeneration,diabetic retinopathy, retinal vaso-occlusive disease, macular edema,macular holes, central serous chorioretinopathy, epiretinal membranes,schisis cavities associated with optic disc pits, retinal inflammatorydiseases, cataracts, and/or glaucoma, may especially benefit from use ofthe system 3050. Patients suffering from dry age-related maculardegeneration are often advised to use an Amsler grid. The Amsler gridresembles a checkboard, but an individual suffering from age-relateddegeneration may find that, while focusing at a dot, straight linesappear wavy and that some of the lines are missing. Thus, by comparingthe appearance of the grid across a time period, the patient may be ableto estimate whether his disease is progressing or improving. However,this test is highly subjective. Use (especially frequent use) of thesystem 3050 could provide a substitute objective measure of a diseasestate and a health care provider may determine a specific result thatmay lead to a recommendation to see the health care provider again.

Patients suffering from wet age-related macular degeneration may receivefrequent, repeated anti-VEGF treatments. The number and/or frequency ofthe treatments may be customized based upon the anatomical state of thepatient's eye/s to reduce the total number of visits required within agiven time period. For example, re-treatment may be indicated if thecentral retinal thickness as measured by OCT increases by at least 100microns, if new or increased cystoid edema is detected, if subretinalfluid is present, or if pigment epithelial detachments increasesubstantially in size. By monitoring the disease with an OCT system 3050described herein, the patient can frequently and conveniently monitordisease characteristics without inconvenient and expensive visits totheir eyecare provider and then schedule an appointment with a healthcare provider if it is probable that a new treatment is required or ifother dangerous conditions develop.

Treatment of conditions such as macular edema and glaucoma is aided byfrequent monitoring of the condition. The OCT systems described hereincan monitor the condition, which may thereby allow more frequentmonitoring and/or reduce inconvenience to the patient and/or health careprovider. With regards to glaucoma, the system could provide morequantitative interval data points for optic nerve and nerve fiber layerassessments.

In some embodiments, one or more data storage devices such as cards (forexample, card with magnetic tape, smart card, USB device) are provided.Data may be transferred to the device(s) via standard data transferringtechniques, such as by using a computer or a magnetic strip encoder andby data transfer and storage devices yet to be developed. The datastorage devices may be configured to store information related to anophthalmic condition, a patient and/or a health care provider. In oneinstance, the devices are configured to receive information from ahealth care provider or an agent of the health care provider. Theinformation to be received from the health care provider may includepatient identification information, such as the patient's name or apatient identifier (for example, number). The information may indicatean ophthalmic condition of which the patient is suffering from or is atrisk of suffering from. The information may indicate a particularophthalmic measurement of interest (for example, an anterior chamberdepth, macular volume, optic disc cup volume, nerve fiber layer volume)or a concerning feature (for example subretinal fluid, macular hole,retinal neovascularization, cystoid spaces, pigment epithelialdetachment) The information may indicate a current ophthalmicmeasurement and/or a threshold of the measurement. The threshold may beabsolute or relative. The information may include information related tothe health care provider, such as his name, business, profession,association, address, email, fax number and/or telephone number. Theinformation may include information about the scan timing. For example,the information may indicate that the patient is to receive a scanwithin a time period or is to receive a specific number of scans. Insome instances, a system will compare the time period on the device tothe current time and only perform an OCT scan and/or only accept thedevice if the current time is within the time period. The informationmay indicate a scan type (for example, full or partial) or a scancharacteristic (for example, a resolution or area to be imaged).

In some instances, the data storage device is configured to be usedmultiple times. For example, the patient may be advised to receive scansaccording to a particular schedule (for example, weekly for ten weeks,or every 2 weeks until a scan result is achieved) and the patient mayuse the same card for each scan visit. In some instances, software or acomponent (for example, an electronics component or a fraud protectioncomponent) is used to determine if the same subject is using the cardmultiple times to prevent fraudulent use of the card by multiple people.In this case, patterns unique to individuals, such as their retinalvessel pattern, may be compared between visits to ensure that the sameperson is being scanned each time. Other biometric measurements may bedeveloped or implemented for this purpose as well. In some instances,the system is configured to require the data storage device (forexample, card) be used within a time period indicated on the datastorage device before scanning the patient's eye/s. In some instances,the data storage device (for example, card) is configured to be usedonly once. The system may be configured to accept the data storagedevice and not return it (confiscate it), thereby disabling the patientfrom using it again. Alternatively, the system may alter a part of thedata storage device (for example, a software component, data on magnetictape) such that the system either does not accept the data storagedevice after a single use or does not perform another scan after thedata storage device is inserted after a single use. Multiple cards canbe issued for a patient who is to receive scans according to aparticular schedule (for example, weekly for ten weeks, or every 2 weeksuntil a scan result is achieved) and the patient may use, for example,one card for each scan visit. (Note that in some embodiments, multiplescans may be provided in one sitting, for example, to investigatemultiple regions of the eye.)

As referred to above, the data storage device (for example, card) maycomprise a writable surface. Thus, the system may print a result on thedata storage device. The result may include a confirmation result, whichcan confirm (for example, to the health care provider) that the scan wasperformed. The confirmation result may include a date and/or a time. Theresult may include an ophthalmic output or other result of the scan.

In narrow-angle or angle-closure glaucoma, a block or obstruction ofdrainage canals can lead to a chronic or rapid increase in eye pressure.Such a block can occur when the iris pushes against the lens of the eye,and the iris and lens may even stick together. Narrow-angle glaucoma ishighly prevalent in areas such as China and India. Thus, it may beadvantageous to identify whether a patient is at risk of developing thiscondition. The depth of the anterior chamber may be associated with theoccurrence of narrow-angle glaucoma in that patients suffering fromnarrow-angle glaucoma generally have shorter anterior chamber depthsthan control subjects. See, for example, Lavanya et al. Screening fornarrow angles in the Singapore population: evaluation of new noncontactscreening methods. Ophthalmology. 2008 May 15, which is herebyincorporated by reference in its entirety. This depth can be calculatedas the distance between the posterior corneal surface and the anteriorlens capsule. Alternative anterior borders for the anterior chamberdepth might be the anterior corneal surface or within the cornealstroma. Alternative posterior borders for the anterior chamber depth maybe the lens body. A corneal thickness (for example, a central cornealthickness) may also be indicative of whether a patient is suffering fromor is at risk of suffering from glaucoma (for example, open angleglaucoma). The central corneal thickness can be measured as the distancebetween the anterior and posterior corneal surfaces at the center of thecornea.

Thus, a system disclosed herein (for example system 100, 3050) may beused to screen for glaucoma, such as narrow-angle glaucoma andopen-angle glaucoma. The self-administered OCT test may be performed onpatients that have or have not been diagnosed with glaucoma. The system100, 3050 may indicate that the patient is suffering from a glaucomacondition, that the patient is at risk of suffering from a glaucomacondition, or may provide an indication of a severity or progression ofthe condition.

The system 100, 3050 may, for example, measure the anterior chamberdepth or corneal thickness of a user and compare the depth to athreshold depth or thickness to determine whether the user is sufferingfrom or is at risk of suffering from a glaucoma condition. If the depthor thickness is beyond a threshold, an output indicating as such may beoutput to the user and/or a health care provider. The output mayindicate the measured depth or thickness, may indicate that the measureddata is within a particular range, may indicate that the measured datais beyond a threshold, and/or may indicate a probability that the useris suffering from a glaucoma condition or optic nerve disorder. Otheroutputs may be provided. Notably, in some instances “beyond a threshold”includes being greater than the threshold, while in other conditions itincludes being less than the threshold. For example, in the instance ofnarrow-angle glaucoma, smaller anterior chamber depths are associatedwith the condition, so beyond the threshold can mean that the measureddepth is less than the threshold. A threshold may include an anteriorchamber depth of about 3.5 mm, 3.3 mm, 3.1 mm, 3.0 mm, 2.9 mm, 2.8 mm,2.7 mm, 2.6 mm, 2.5 mm, 2.4 mm, 2.3 mm, 2.2 mm, 2.1 mm, 2.0 mm, 1.5 mmor 1.0 mm. Notably, the threshold value may balance sensitivity andspecificity, such that some thresholds are more likely to detect alloccurrences of a disease but also more likely to include falsepositives, while other thresholds are likely to miss more actualoccurrences of the disease but also will be associated with fewer falsepositives. The output may indicate a probability that the patient issuffering from a disease based on how far a measurement is beyond athreshold or which threshold of a plurality of thresholds themeasurement is beyond. In various embodiments, however, a riskassessment is provided.

An OCT measurement may indicate a risk of suffering from a condition. Insome instances, a relationship (for example, a monotonic relationship)may be established between the measurement and a probability of havingthe condition. This relationship may be established based on empiricaldata. Thus, the measurement may be converted into the probability orrisk of suffering from the disease. In some instances a relationship maybe established between the measurement and the probability of laterhaving the condition. Thus, preventative measures may be taken in orderto reduce this probability. In some instances, a number of measurementranges are established, each range being associated with a (present orfuture) probability of having the condition.

In various embodiments, the system 100, 3050 may measure the anteriorchamber depth or a corneal thickness of a user, for example, and comparethe depth to a previously measured depth or thickness to determinewhether the condition is improving or worsening. The previously measureddata may be loaded from a storage component. The output may indicatethat the condition is improving, worsening or substantially the same.The output may quantify a change in a condition-related measurement. Theoutput may indicate whether the change is beyond a threshold amount.

In some instances, the anterior segment of the eye is imaged byappropriate positioning of the Z-offset adjustment stage 290. In someinstances, the quality of the scan at least partly determines whichanatomical structures are used for the boundaries defining the anteriorchamber distance. The posterior corneal surface and the anterior lenssurface may be used as the anterior and posterior boundaries,respectively, when the quality is high, whereas the corneal stroma maybe substituted as the anterior boundary and/or the lens body may besubstituted as the posterior boundary when the quality is low.

In some instances, an A-scan may be used to determine a thickness ordepth. However, the depth or thickness may depend on a radial locationof the scan. Therefore, a B-scan or set of A-scans may be obtained and afirst thickness or depth may be determined for each A-scan. Thethickness or depth with the largest value or at a certain distance fromthe central axis of the eye may be determined to be a useful thicknessor depth to be used in comparisons or as output.

OCT systems may position a Z-offset adjustment stage 290, therebyadjusting the portion of the eye being imaged, and adjustable optics 210may then focus the beam such that a particular small region can beclearly imaged. For some OCT applications, it is desirable to obtainscans through small regions (for example, through an axial distance ofabout 2.2 mm) of the eye. Instruments designed specifically for smallerregions may be able to image the regions with higher resolution.However, limiting the range of the scan to such a short depths mayprevent capture of an entire region of interest. For example, an A-scanthrough a depth or longitudinal distance of 2.2 mm may be too small toinclude both an anterior and posterior boundary of the anterior chamberin the A-scan. In one instance, larger A-scans (for example, overdistances in the Z direction of about 3 or of about 4 mm) may beobtained, such that both the anterior and posterior boundaries of theregion may be imaged. In some instances, the system is configured suchthat all scans extend over the longer range of depths. In someinstances, the system is configured such that all scans of a particularregion (for example, the anterior segment) extend over a larger range ofdepths but that all scans of other regions extend over shorter ranges,thereby allowing higher resolution imaging at the other regions. In someinstances, the system is configured such that scans of a particularregion (for example, the anterior segment) may extend over a longer or ashorter (for example, depending on a setting or particular test) rangeof depths. In some instances, both larger and short length A-scans of aregion are obtained.

In another instance, a plurality of scans is obtained, each of the scansperformed at a different depth. For example, a first scan may adjust atleast one optical component to image an anterior boundary of a region,while a second scan may adjust the at least one component to image at aposterior boundary. For example, the Z-offset adjustment stage 290 andthe adjustable optics 210 may be positioned such that the posteriorcorneal surface is imaged and an A-scan may be obtained. The Z-offsetadjustment stage 290 and the adjustable optics 210 may then bepositioned such that the anterior lens surface is imaged and anotherA-scan may be obtained. The distance between these anatomical featuresmay be determined based on the combination of the different positions ofthe features within the A-scans and the different positions of theZ-offset adjustment stage.

In some instances, a plurality of A-scans is obtained thereby imagingselected portions or possibly a substantial portion of the width or theentire width of the anterior chamber. In these instances, the peripheralchamber depth, angle geometry and/or angle structures may be determined.These measurements may be used to determine that the patient issuffering from a condition (for example, narrow-angle glaucoma), thatthe patient is at risk of suffering from a condition, or may provide anindication of a severity or progression of a condition.

Other variations are possible. For example, since central cornealthickness may also have some predictive value (and can be calculated bymeasuring the distance between the anterior and posterior cornealsurfaces), this measure might also be used for screening for open angleglaucoma.

Another method of monitoring glaucoma may be to estimate the optic nervehead volume by subtracting the volume of the optic disc cup (generally,the depression in the middle of the optic nerve) from the volume ofoptic nerve tissue bounded by the vitreous (on the anterior side), thelamina cribrosa or bottom of the optic disc cup (on the posterior side),and the circumferential retinal pigment epithelium (RPE) and Bruchsmembrane termination that bounds the optic nerve on all or substantiallyall sides. Generally, as glaucoma progresses, the optic nerve volume maydecrease as the nerve fibers die or atrophy, and/or the optic disc cupmay increase relative to the area covered by the optic nerve fibers inthe optic nerve head. Therefore, the OCT system described herein can beconfigured to estimate the amount of remaining optic nerve tissue bysubtracting the optic disc cup volume from the known bounded optic nervetissue volume. The optic disc cup volume can be measured by firstdetecting the posterior border of the optic disc cup with image analysisroutines, such as edge detection, that delineate the transition fromvitreous to optic nerve tissue. The anterior optic disc cup boundary isan imaginary plane cutting through vitreous tissue or aqueous andspanning the peaks of the optic nerve tissue much like a plate placed ona bowl. It can be approximated by detecting the highest point of opticnerve tissue (transition from vitreous to optic nerve tissue) for 360degrees around the optic nerve circumference with image analysisroutines such as edge detection. In another embodiment, thecircumferential termination of Bruchs membrane can be used to delineatethe circumference of the optic nerve. The position of the transitionfrom vitreous to optic nerve tissue at this circumference could be usedas an alternate anterior optic disc cup boundary plane. Alternatively,the system can be configured to compare measurements of optic nerve headvolume, and/or other optic nerve, retinal nerve fiber layer and/orretinal thickness measurements, between the eyes of a subject (and/or atdifferent periods of time) to estimate the risk of glaucoma.

With reference to FIG. 22, there is illustrated an OCT system 2208 fordetecting the major causes of amblyopia: strabismus, anisometropia,isoametropia, and visual occlusion. In general, amblyopia can occur whenthe best-corrected visual acuity in one or both eyes is reduced but thedecreased vision cannot be attributed to abnormalities in the structureof the eye or the posterior visual pathway. For example, a normal eyeand an eye with one of the above-mentioned predisposing conditions (forexample, strabismus, anisometropia, isoametropia, and visual occlusion,and the like) can project two images to the brain, and there can likelybe discrepancies between the two images and/or both images can besubstantially unfocused. In response to the two images, a child's braincan likely adapt because the brains of children are more neuroplastic,and in some situations, the brain will respond by suppressing the imagefrom one of the eyes. Such a response from the brain can interfereand/or interrupt the brain's normal development, resulting in amblyopia.Accordingly, amblyopia is generally a disorder of the visual system thatcan be characterized by poor and/or indistinct vision in an eye that isotherwise physically normal. Generally, amblyopia can be caused bystrabismus, anisometropia or isoametropia, and/or occlusion of one orboth eyes. Strabismus is a condition in which the eyes are misaligned(horizontal, vertical, torsional, or any combination of the foregoing).Anisometropia is a condition in which the eyes have unequal refractivepower or optical power or dioptric power. Dioptric power can begenerally defined as the combined power of the cornea and eye lens, andmore specifically, it is the inverse of focal length. In general,dioptric power can be expressed in three-component form of sphere,cylinder, and axis. Isoametropia is a condition in which both eyes havesubstantially equal refractive power (or refractive errors within athreshold range) but have abnormal refractive errors. Occlusion is acondition in which light is blocked from reaching the retina, and suchblockage can be caused by the ocular media becoming opaque, for example,with cataracts or corneal scarring. Detection of amblyopia in earlychildhood can increase the chances of successful treatment. Failure todetect amblyopia until young adulthood usually results in irreversiblevision loss. Accordingly, there is a need for an OCT system fordetecting causes of amblyopia in children so early treatments can beimplemented. Detection of these predisposing disorders in adults is alsoimportant since they may be acquired during adulthood and may reflectunderlying neurologic or other systemic diseases.

In reference to FIG. 22, there is illustrated a high-level flow diagramdepicting an example of using an interpupillary distance measurementdevice 2204 on a patient/subject (for example, an infant or an adult) todetermine the approximate and appropriate interpupillary distance forthe binoculars without subjective participation of the subject (such as,a child or uncooperative adult). The interpupillary distance measurementdevice 2204 and/or the OCT system 2208 can be used on children 2202and/or adults and/or other mammals (also referred to herein as subjectsand/or patients). In various embodiments, the interpupillary distancemeasurement device 2204 can be a separate device held up to the eyes andface of a subject. The interpupillary distance measurement device 2204can be reusable, disposable, and/or a one-time use device. Theinterpupillary distance measurement device 2204 can be separate from orattached to the OCT system 2208.

With reference to FIG. 22, the interpupillary distance measurementdevice 2204 can be configured to attach to the subject's/patient's 2202face and/or be positioned over the subject's/patient's eyes. Theinterpupillary distance measurement device 2204 can comprise openings2207, which can be configured to go over and/or be aligned with the eyesof the subject. In various embodiments, the openings 2207 can be smalleror larger depending on the size of the eyes or other features of theeyes (for example, iris, pupil, or the like). In various embodiments,interpupillary distance can be better estimated when the openings 2207are sized to substantially match the eye (or iris, pupil, or the like)size of the subject. The interpupillary distance measurement device 2204can be used by the subject/patient or a user assisting thesubject/patient. In various embodiments, the interpupillary distancemeasurement device 2204 can be configured to comprise a row ofholes/openings 2205 to be used as a horizontal adjustment mechanismand/or locking mechanism for the device having two pieces that slidewith respect to each other depending on the interpupillary distance. Theinterpupillary distance measurement device 2204 can be manufactured fromplastic, metal, cardboard, or other similar materials, and can bereusable and/or disposable. As the two pieces slide with respect to eachother, the pieces can be snapped and/or locked into place along the rowof holes/openings 2205. The interpupillary distance measurement device2204 can also comprise flanges 2206 or other measurement guide, whichcan be configured to change in dimension or width based on the measuredinterpupillary distance. In various embodiments, the dimensions or widthof the flange or other measurement guide can be used as width guidesthat can be positioned between the barrels of the binoculars on the OCTinstrument. By closing the pair of oculars of the OCT system 2208 on theflanges 2206, or horizontally shifting the binoculars of the OCT system2208 to conform to the size of the flanges 2206, the binoculars of theOCT system 2208 can be adjusted to conform to the interpupillarydistance estimated using the interpupillary distance measurement device2204. In various embodiments, the interpupillary distance measurementdevice 2204 can be fitted to the subject's/patient's eyes byhorizontally sliding the interpupillary distance measurement device 2204to fit over the eyes of the subject/patient 2202 or using preplacedholes in the device. Alternatively, the interpupillary distancemeasurement device 2204 can be connected (for example, electronicallythrough a wire and/or wireless connection, and/or mechanically) to theOCT instrument to transfer the measured interpupillary distance to theOCT instrument.

As illustrated in FIG. 22, the interpupillary distance measurementdevice 2204 (which can help align the OCT imaging system with theoptical axes of the two eyes, or match up the OCT imaging system withthe pupils, irises, or the like) can generally be configured todetermine the subject's interpupillary distance with minimal cooperationfrom the subject. The OCT system 2208 can then be adjusted to conform tothe fitted interpupillary distance measurement device 2206.Alternatively, the fixation targets, such as simple or othershapes/objects (for example, houses, balls, animals, or the like) ormovies may be projected into the eyes of the subject/patient tofacilitate self-adjustment by the subject/patient. In anotherembodiment, manual adjustment of the interpupillary distance can bereplaced with automated methods based on pupil tracking. In variousembodiments, fast pairs of horizontal and vertical retinal B-scans couldbe used to center the system on the optical axis of the subject. Whenthe system is correctly centered, the maximum lateral extent of bothhorizontal and vertical B-scans can be visualized. Decentration of thescanning light source beam in any direction can be detected as prematurecontact with the pupillary border (iris tissue) in one direction leadingto truncation of the B-scan signal in that lateral direction. With theOCT system 2208 properly fitted and/or correlated to the user's eyes,the OCT system 2208 can obtain OCT measurements, as described herein, toproduce OCT images 2210, 2212. The OCT system 2208 can be configured toanalyze the OCT images 2210, 2212 to perform risk assessments, generatediagnoses, and/or detect the causes of amblyopia and/or adultstrabismus, anisometropia, visual occlusion, and the like.

In reference to FIG. 23, there is illustrated a high-level process flowdiagram depicting an example process for using an OCT system to detectthe causes of amblyopia and/or adult strabismus, anisometropia, visualocclusion, or the like. As indicated, the process flow can begin atblock 2302 where at block 2304 the computer system 104 can be configuredto optionally obtain the OCT data (sequentially or simultaneously) forthe left and/or the right eye(s) and use the OCT data to estimate atblock 2304 the approximate axial (z) position of the anterior segmentand/or the corneal Z-offset by determining an increase or an initialonset of OCT signal, or by substantially maximizing OCT signal strength.The corneal Z-offset can be the location of the cornea with respect tothe OCT instrument. The corneal Z-offset in combination with the retinalZ-offset can be used to determine the axial length of the eye. Invarious embodiments, the computer system 104 can be configured to usecorneal Z-offset in combination with other parameters to determineand/or calculate the refractive error of the eyes. In variousembodiments, the computer system 104 starts at a presumed location ofthe cornea based on the position of the binocular eyecups, and adjuststhe Z-offset stage within the main body 106 to determine which Z-offsetposition produces the substantially strongest OCT signal strength (orincreased or elevated OCT signal strength). This substantially strongestOCT signal strength correlates with a Z-offset position that places thecornea and anterior segment of the eye within the imaging portion of theOCT system. In various embodiments, the approximate corneal Z-offset forboth eyes is stored and/or outputted at block 2308.

In FIG. 23, at block 2306, the computer system 104 can be configured tooptionally refine the estimated corneal Z-offset and/or generate a moreaccurate corneal Z-offset by using an auto-focus system (as describedherein) to focus on the anterior segment of the OCT image, therebyallowing for more accurate corneal Z-offset measurements. Alternatively,the computer system 104 at block 2309 can be configured to optionallysegment the cornea (outline the anterior and posterior boundaries of thecorneal tissue) using imaging techniques, such as, for example, edgedetection methodologies or the like, to determine the substantiallyfront location of the cornea. In various embodiments, the front locationor substantially front location of the cornea will generally produceand/or result in an OCT signal with substantially maximum signalstrength. In determining the location that produces the substantiallymaximum OCT signal, the computer system 104 can determine the cornealZ-offset, which can be outputted and/or stored at block 2308.

In reference to FIG. 23, the computer system 104 can be configured toobtain the OCT data (sequentially or simultaneously) for the left and/orthe right eye(s) and/or foveolae, and use the OCT data to estimate atblock 2310 a retinal Z-offset by determining the location of the averagemaximum OCT signal in all A-scans of a B-scan or by substantiallymaximizing OCT signal strength. The retinal Z-offset can be the locationof the retina with respect to the OCT instrument. The retinal Z-offsetcan be used in combination with other parameters to determine and/orcalculate the refractive error of the eyes. In various embodiments, thecomputer system 104 starts at a presumed location of the retina, andadjusts the Z-offset stage within the main body 106 to determine whichZ-offset position produces the substantially strongest OCT signalstrength, or increased or elevated OCT signal strength. Thissubstantially strongest OCT signal strength (or increased or elevatedOCT signal strength) correlates with a Z-offset position that places theretina of the eye within the imaging portion of the OCT system. Invarious embodiments, the estimated retinal Z-offset for both eyes isstored and/or outputted at block 2314.

In FIG. 23, at block 2312, the computer system 104 can be configured tooptionally refine the estimated retinal Z-offset and/or generate a moreaccurate retinal Z-offset by using an auto-focus system (as describedherein) to focus on the posterior segment of the OCT image, therebyallowing for more accurate retinal Z-offset measurements. Alternatively,the computer system 104 at block 2315 can be configured to optionallysegment the retina using imaging techniques, such as edge detectionmethodologies, to determine the anterior or posterior border of theretina. In various embodiments, the front, center or back of the retinawill generally produce and/or result in an OCT signal with substantiallymaximum signal strength, or increased or elevated OCT signal strength.In determining the location that produces the substantially maximum OCTsignal (or increased or elevated OCT signal strength), the computersystem 104 can determine the retinal Z-offset, which can be outputtedand/or stored at block 2314. In determining the auto-focus lens positionthat produces the most focused image of the retina, the computer system104 can be configured to store and/or output the position of theauto-focus lens for both eyes at block 2316. The auto-focus lensposition that produces the most focused retinal image and therefore thesubstantially strongest OCT signal strength (or increased or elevatedOCT signal strength) can be used in combination with other parameters todetermine and/or calculate the refractive error of the eyes.

With reference to FIG. 23, the computer system 104 can be configured toanalyze the corneal Z-offset and the retinal Z-offset to determinewhether the axial length of the eye is greater or less than a thresholdvalue. In various embodiments, the threshold value is determined byclinical studies and/or observations, for example, if the axial lengthof the eye is greater than 25 mm then the subject/patient is at a higherrisk for various eye diseases or abnormalities. In various embodiments,refractive error can be determined by the OCT system. For example, theposition of the auto-focus lens system can be adjusted so that the probebeam and/or the fixation target is focused on the retina. The positionof the auto-focus lens system (see, for example, block 2316) can then beused to determine the vergence of light exiting the main body lenssystem. Using the distance to the cornea from block 2308, the vergenceof the light as it hits the cornea can also be calculated. Since the OCTinstrument is optimally focused on the retina, this means that thevergence of light entering the cornea is essentially counteractedcompletely to focus on the retina. This vergence of light entering thecornea is therefore a very close approximation to the sphericalequivalent refractive error in the eye. In another embodiment, lenses tocorrect astigmatic errors, such as Stokes' lenses, could be introducedinto the instrument's light path. In various embodiments, the Stokes'lenses can be in the non-collimated light path. In certain embodiments,the Stokes' lenses can be in the autofocus lens system in the oculars.The position/orientation of these lenses that produces a substantiallyincreased, peaked, or most the focused retinal image could bedetermined, for example, after determination of the general sphericalerror correction as described previously.

With reference to FIG. 23, at block 2318, the computer system 104 can beconfigured to analyze the OCT data to determine the dioptric powerand/or the refractive error of the left and/or right eyes. In variousembodiments, the computer system 104 can be configured to determine thedioptric power and/or the refractive error of each eye by correlatingmeasured OCT data parameters to a database and/or lookup table. Invarious embodiments, the database and/or lookup table can be generatedbased on clinical studies and/or observations, wherein data parameters,such as corneal Z-offset, retinal Z-offset, and auto-focus lensposition, are correlated to observed refractive errors. Using thedatabase and/or the lookup table, the computer system 104 can beconfigured to correlate/lookup the retinal Z-offset value of an eye(block 2314) and the position of the auto-focus lens for the eye (block2316) (both as independent variables) to determine and/or derive arefractive error for the eye. In various embodiments, the computersystem 104 can be configured to correlate/lookup the corneal Z-offsetvalue of an eye (block 2308), the retinal Z-offset value of the eye(block 2314), and the position of the auto-focus lens for the eye (block2316) (as independent variables) to determine and/or derive a refractiveerror for the eye. Other combinations of variables can be possible.

In reference to FIG. 23, the computer system 104 can be configured toanalyze the refractive error and/or dioptric power (or the differencebetween refractive errors) to detect causes of amblyopia, such as, forexample, anisometropia, isoametropia, and/or the like. In variousembodiments, the computer system 104 can be configured to determinewhether the refractive error and/or the dioptric power (or thedifference between refractive errors) is above and/or below a thresholdvalue, or within a threshold range. For example, at block 2320, thecomputer system 104 can be configured to determine the differencebetween the refractive errors for the left and right eyes, and determinewhether the difference is within 3 diopters in the myopic range, orwithin 1.5 diopters in the hyperopic range. In various embodiments, thecomputer system 104 can be configured to determine whether thedifference between the refractive errors for the left and right eyes iswithin a 1-5 diopters in the myopic range, or within 1-3 diopters in thehyperopic range. If the difference between the refractive errors for theleft and right eyes is not within the threshold range (for example, 3diopters myopic, or within 1.5 diopters hyperopic), then the computersystem 104 can be configured to output at block 2322 that anisometropiahas been detected.

With reference to FIG. 23, the computer system 104 can be configured toperform another threshold analysis, if the difference between therefractive errors for the left and right eyes is within the thresholdrange (for example, 3 diopters myopic, or within 1.5 dioptershyperopic). For example, if the difference between the refractive errorsfor the left and right eyes is within the threshold range (for example,3 diopters myopic, or within 1.5 diopters hyperopic), then at block 2324the computer system can be configured to determine whether therefractive errors for both eyes (also known as OU or Oculus Utro) isgreater than −10 diopters in the myopic range and less than +5 dioptersin the hyperopic range. If the refractive errors for both eyes are notbetween −10 diopters and +5 diopters, then the computer system 104 canbe configured to output at block 2326 that isoametropia has beendetected. If the refractive errors for both eyes are between −10diopters and +5 diopters, then the computer system 104 can be configuredto output that neither anisometropia nor isoametropia has been detected,or in various embodiments, the computer system 104 can be configured tooutput nothing and/or perform other analyses.

In FIG. 23, at block 2328, the computer system 104 can be configured toperform other analyses. For example, the computer system 104 can beconfigured to obtain OCT data for the left and right eyes while twofixation targets are presented to the subject/patient to generateB-scans for both eyes. Since these fixation targets are near to thesubject's eye, various techniques could be used to simulate bilateraldistance fixation including lateral displacement of the fixation targetswith respect to each other. Additionally, in some embodiments,collimation of the light between display 215 a and mirror 230 a or 215 band 230 b can be used to simulate the target at a large distance (forexample, infinity). Optics such as a computer-controlled lens system orcollimator, for example, between display 215 a and mirror 230 a or 215 band 230 b can be employed to produce the collimation, if the distancefrom the display 215 a, 215 b is not already sufficiently large.Similarly, near targets could be simulated by diverging the lightbetween 215 a and 230 a or 215 b and 230 b to simulate targets atreading distance (typically 14 inches) or computer distance (typically30 inches). This could be accomplished with a computer-controlled lenssystem inserted into the light path, for example, between display 215 aand mirror 230 a or 215 b and 230 b. Different target distances couldalso be simulated. Measurements of refractive error as the distance tothe fixation targets is changed could be used to estimate theaccommodative amplitude. For example, if no refractive error is found toexist when the fixation target is at infinity (collimated light), thenmeasurement of the appearance of a small amount of refractive error whenthe fixation targets are at 20 cm would imply that the eye has anaccommodative amplitude of 5 D. Measurement of the full range ofaccommodative amplitude of an eye could be advantageous for determiningthe true refractive error in an eye that is accommodating on a nearfixation target. Other techniques could be used to relax accommodationduring the process of measuring refractive error, especially inchildren, including adding additional plus lenses, such as +2.0 D, +3.0D or +2.5 D, into the light path to ‘fog’ the fixation target orremoving the fixation target from view prior to autorefraction todetermine the range of refractive errors in a user's eye.

At block 2332, the computer system 104 can be configured to determinewhether the retina is visible. In various embodiments, the computersystem can be configured to review the histogram of the B-scan images,and if the pixel distribution in the histogram is below a thresholdvalue, than the computer system 104 can be configured to determine thatthe retina is not visible. In another embodiment, the OCT signalstrength can be used to determine if the retina is visible within theOCT imaging area. For example, if the signal-to-noise ratio of the OCTB-scan falls below a pre-determined and/or dynamically determinedthreshold value, such as, for example, 10, 20, or 30 (which can beunitless threshold values because each is a ratio of signals in similarunits), for existence of the retina within the image, the computersystem 104 can be configured to determine that the retina is notvisible. One skilled in the art will appreciate that there are otherways to determine whether the retina is visible. If the retina is notvisible, then the computer system 104 can be configured to output atblock 2334 that wide angle strabismus and/or visual occlusion may havebeen detected. If the retina is detected, then the computer system 104can be configured to detect the foveolae in both eyes at block 2336.

As illustrated in FIG. 23, the computer system 104 at block 2336 can beconfigured to analyze the OCT data to determine the location of thefoveal depressions in the eyes. The fovea can be located in severalways. For example, the inner retina can be detected using edge detectionmethods and fit to a polynomial curve. The substantially maximal fovealdepression could be detected as the substantially maximal edge-detecteddeviation downward from this polynomial curve. In various embodiments,the degree of confidence in foveal detection can be measured as thedeviation from the polynomial curve. Alternatively, since the outernuclear layer comprises nearly 100% of the retina thickness in thefoveola, the fovea can be detected by looking for the area with nearly100% outer nuclear layer composition to the retina. Other ways in whichthe fovea can be detected are to look for focally increased thickness ofthe photoreceptor outer segments, substantially maximal separation ofthick nerve fiber layer and location of a bright foveal reflex at thevitreoretinal interface. Still other approaches are possible. If thecomputer system 104 cannot locate the foveolae at block 2338, then thecomputer system 104 can be configured to output at block 2340 that thewide angle vertical or a combination of vertical and horizontalstrabismus has been detected. If the computer system 104 can locate thefoveal depressions at block 2338, then the computer system 104 can beconfigured to determine at block 2342 whether the foveolae are insubstantially the same position.

With reference to FIG. 23, the computer system can be configured todetermine at block 2346 the type and/or degree of misalignment in thefoveolae, if the foveolae are not in substantially the same position. Ifthe eye deviation is outward (as determined, for example, by analyzingwhether the location of the fovea is located within a threshold range),then the computer system 104 can be configured to output at block 2348that exotropia has been detected. If the eye deviation is inward (asdetermined, for example, by analyzing whether the location of the foveais located within a threshold range), then the computer system 104 canbe configured to output at block 2350 that esotropia has been detected.If the locations of the foveal depressions are substantially the same,for example within a pre-determined threshold distance, then thecomputer system 104 can be configured to output at block 2344 that theeyes are within normal limits.

With reference to FIG. 27, the computer system 104 can also beconfigured to use optical coherence tomography measurement data and/orother data to estimate the angular misalignment, such as, for example,horizontal misalignment, vertical misalignment, or combinations thereof,between the two eyes to guide prism measurements for glassesprescriptions. For example, if one foveola in a first eye is found to becentered in a first B-scan while the other foveola in a second eye asobserved in a second B-scan is found to be displaced by a distance 2702of 1000 microns, this forms the short leg of the right triangledescribing the angular difference between the two eyes. The long leg ofthe right triangle describing the angular difference between the twoeyes can be determined with an axial measurement, such as, for example,the distance 2704 between the cornea and retina or the lens and theretina as described herein. By using the Pythagorean theorem, theangular displacement between the two eyes can be estimated from the arctangent of the ratio of these two distances. This value could betranslated into prism diopters required to center the foveola in thesecond eye as detected in the second B-scan. Alternatively, instead ofcalculating the explicit angular difference, the foveolae distance 2702and/or the cornea-retina distance, and/or the lens-retina distance,and/or the iris-retina distance, and/or the axial length of the eye,and/or other distance measurements, could be looked up in a databasecomprising known deviations/measurement and prism lens prescriptions(for example, a database generated based on clinical data and/orstudies) to determine the prism measurements that correspond to thesemeasurements. The process of estimating angular misalignment can be usedfor determining or analyzing tropias (for example, manifestmisalignments of the eyes) and/or phorias (for example, latentmisalignments of the eyes that can be elicited by breaking and/ordisrupting fixation) as both are described herein.

As illustrated in FIG. 23, the computer system 104 can be configured atblock 2344 to perform additional testing on the eyes. For example, thecomputer system 104 can be configured to perform an additional test todetect phoria at block 2345 if the eyes are found to be substantiallyaligned. Generally, phoria is a latent deviation in the eye, and suchlatent deviation in the eyes can occur when fusion is broken. Insubjects/patients with phoria, the natural resting position of the eyemuscle system is not generally straight (ortho). Accordingly, when thesubject/patient is visually active (for example, awake and/or alert),then the power of fusion keeps the eyes straight but if fusion is brokenby dissimilar visual targets, then the eyes can generally move to theirnatural resting positions (for example, eso, exo, or hyper). To detectphoria, the computer system 104 can be configured to project and hidevarious images in or shown to the eyes of the subject, therebysimulating cover/uncover, cross-over, and/or other commonly-usedorthoptic techniques to disrupt or augment fixation. For example, atblock 2345, the computer system 104 can be configured to manipulate thefixation targets to simulate cover/uncover, cross-cover, or otherorthoptic techniques to change fixation to generate additional B-scansto detect phoria. The computer system 104 can be configured to analyzethe additional B-scan images by processing the image as discussed abovein connection with blocks 2332 to 2350 (for example, to identifymisalignment in visual axis based on location on the location of thefoveolae, etc.).

In FIG. 24, there is illustrated a high-level flow diagram of an exampleprocess for using an OCT system to determine dioptric power based on theOCT signal detected. In various embodiments, the process illustrated inFIG. 24 is the process employed to perform the actions in blocks 2312and 2318 of FIG. 23. As indicated, the process flow can begin at block2402 where at block 2404 the computer system 104 can be configured toobtain the OCT data for the left and/or the right eye(s) from the OCTmeasurement device 2406 to determine the OCT signal strength at thecorresponding optic lens location (for example, adjustable optics 210 inFIG. 3A and the like). At block 2408, the computer system can beconfigured to store the OCT signal strength and the corresponding opticlens location in the OCT signal values memory 2410. At block 2412, thecomputer system 104 can be configured to adjust the location of theoptic lens in the OCT measurement device 2406 that affects theconvergence or divergence or focus of the laser beam into the subject'seyes. At block 2414, the computer system 104 can be configured todetermine whether the optic lens can be adjusted to a differentposition. If the lens can be adjusted to a different position, then thecomputer system 104 can be configured repeat the process at blocks 2404,2408, and 2412. If the lens cannot be adjusted to a different position,then at block 2416 the computer system 104 can be configured todetermine the optic lens position providing the peak OCT signal strengthby analyzing the OCT signal values stored in the OCT signal valuesmemory 2410. One skilled in the art will recognize there are other waysto configure the computer system 104 to determine the optic lensposition providing the peak OCT signal strength, such as identifying aoptic lens position producing a signal strength that is higher than thesignal strength produced by the two adjacent optic lens positions. Atblock 2418, the computer system 104 can be configured to determinedioptric power based on the position of optic lens, retinal Z-offsetlocation, and optionally, the corneal Z-offset location. At block 2422,the computer system 104 can be configured to output the dioptric powerof the subject's/patient's eyes.

With reference to FIG. 25, there are example illustrations of OCTsystem-generated images of retinas. Elements 2502 and 2504 representexamples of OCT system-generated images illustrating normal binocularfixation as exhibited by the two central foveolae positionedsubstantially in the same position, thereby indicating no strabismus ormisalignment of the eyes. In this example, the OCT system can beconfigured to measure the focus of each eye, and has determined that thedioptric power of each eye is substantially the same. The OCT system canbe configured to output that the causes of amblyopia (or strabismus,anisometropia, and visual occlusion) have not been detected in thisexample. Elements 2506 and 2508 represent examples of OCTsystem-generated images illustrating strabismus or misalignment of theeyes, and in this case, there is horizontal deviation. As illustrated inelement 2508, the fovea is displaced nasally, therefore the foveolae arenot substantially in the same position. In this example, the OCT systemcan be configured to output that strabismus has been detected, andspecifically, exotropia (deviation of the eyes outward, as opposed toesotropia, which is inward deviation of the eyes).

In reference to FIG. 25, elements 2510 and 2512 represent examples ofOCT system-generated images illustrating strabismus, wherein the foveais visible in the oculus sinister (also known as OS, meaning left eye)but the fovea is not visible in the oculus dexter (also known as OD,meaning right eye). Here the strabismus could be caused by manycombinations of deviations such as a vertical and/or horizontaldeviation. In this example, the OCT system can be configured to outputthat strabismus of an unknown type has been detected. Elements 2514 and2516 represent examples of OCT system-generated images illustratinganisometropia wherein both foveolae are visible but each eye has adifferent or substantially different dioptric power or focus. Here, theOCT can be configured to determine the focus, optical power, refractivepower, or dioptric power, for example, the OS dioptric power can be −1.5whereas the OD dioptric power can be −7.0. In this example, the OCTsystem can be configured to output that no strabismus has been detectedbut that anisometropia is present based on the process described abovein blocks 2318-2326. Elements 2518 and 2520 represent examples of OCTsystem-generated images illustrating visual occlusion from obstructionor wide-angle strabismus, wherein the fovea is visible in the oculussinister (also known as OS, meaning left eye) but the retina is notvisible in the oculus dexter (also known as OD, meaning right eye). Inthis example, the OCT system can be configured to output that therecould be an occlusion of the right eye (for example, cataract) or therecould be large angle deviation in the right eye.

In reference to FIG. 26, there is illustrated a high-level block diagramschematically depicting components in one embodiment of the computersystem for the optical coherence tomography systems described herein. Asdescribed above in connection with FIG. 13, the methods, systems, anddevices described herein can be implemented using the computing system1300 illustrated in FIG. 13. The module 2602 for detecting the causes ofamblyopia, such as, for example, strabismus, anisometropia, and visualocclusion, (the AVI detection module 2602) can be connected to or incommunication with any of the devices, components, controls, modules,interfaces, and/or databases in or connected to the computer system 104.For example, the AVI detection module 2602 can be configured to connectto or communicate with the main body device 106 to obtain OCT datameasured from the subject's/patient's eye. In various embodiments, theAVI detection module 2602 can be configured to connect to or communicatewith the authentication module 816 to determine the subject/patientidentification and/or associate an evaluation output with asubject/patient.

In connection with FIG. 26, the AVI detection module 2602 can also beconfigured to connect to or communicate with the focus adjust module 820to obtain the dioptric power of the subject's/patient's eye(s).Alternatively, the AVI detection module 2602 can be configured to obtainthe dioptric power of the subject's/patient's eye(s) by connecting to orcommunicating with the dioptric power detection module 2604, which canbe configured to communicate with or connect to the focus adjust module820. In various embodiments, the AVI detection module 2602 can also beconfigured to connect to or communicate with the scanning analysismodule 824 to obtain OCT data/information measured from thesubject's/patient's eye(s) using the main body 106. The AVI detectionmodule 2602 and/or the dioptric power detection module 2604 can beconfigured to connect to or communicate with the reporting/output module806 in order to output an evaluation data and/or report and/or dioptricpower measurements of the subject's eyes on the output device 102. Invarious embodiments, the AVI detection module 2602 can be configured toconnect to or communicate with the network interface 812 and/or thefirewall 814 in order to output, send, and/or communicate overcommunications medium 108 an evaluation data and/or report to thebilling/insurance reporting and payment systems 1201 and/or the remotesystems 110. The AVI detection module 2602 can be configured to connectto or communicate with the user interface module 805 to output anevaluation data and/or report to the user/patient.

With reference to FIG. 26, the AVI detection module 2602 can beconfigured to connect to or communicate with the images/scans database826, and/or the user/patient database 802, and/or the disease riskassessment/diagnosis database 808. In various embodiments, the AVIdetection module 2602 can be configured to connect to or communicatewith the images/scans database 826 and/or the user/patient database 802to determine and/or obtain prior or previous evaluation data and/orreport(s). The AVI detection module 2602 can be configured to compareand/or analyze the prior/previous evaluation data/report(s) with thecurrent evaluation data/report to determine/detect any changes and/ortrends in a subject's/patient's condition. In various embodiments, theAVI detection module 2602 can be configured to output to the user areport comparing current data with prior/previous data. If thedifference between the current and prior/previous data exceeds athreshold level, such as 0.25 D, 0.5 D, 0.75 D or 1.0 D, and/or isoutside a threshold range such as 1.0 D then the AVI detection module2602 can be configured to output/recommend to the user/patient that thepatient consult with a doctor, and can output physician referrals nearthe patient. In various embodiments, the threshold level and/orthreshold range data can be stored in the disease riskassessment/diagnosis database 808. In various embodiments, the AVIdetection module 2602 can be configured to output/recommend to theuser/patient that the patient consult with a doctor, and can outputphysician referrals near the patient, based on comparing and/oranalyzing threshold data values (for example, derived from clinicalobservations and/or studies) with the current evaluation data/report todetermine/detect any differences and/or changes and/or trends in asubject's/patient's eyes. The foregoing can occur when the patient hasno historical and/or prior/previous amblyopia evaluation data/report(s).In various embodiments, the AVI detection module 2602 can be configuredto output/recommend to the user/patient that the patient consult with adoctor, and can output physician referrals near the patient, based oncomparing and/or analyzing the subject's current corrective lenses (suchdata can be provided by the subject or stored in a database and/or theuser's identification card and/or measured by the OCT instrument) withthe current evaluation data/report to determine/detect any differencesand/or changes and/or trends in a subject's/patient's eyes.

Ophthalmic Testing Center

Generally, the OCT-based ophthalmic testing center system describedherein can be configured to perform a multitude of functional and/orstructural ophthalmic testing procedures, including, but not limited to:corneal topography, corneal pachymetry, autorefraction, biomicroscopy,visual acuity testing, photostress recovery time testing, color visionassessments, gonioscopy, central vision distortion testing, readingspeed assessments, contrast sensitivity testing, fixation stabilitytesting, static perimetry, kinetic perimetry, confrontation visualfields, stereoacuity testing, suppression testing, ocular alignmenttesting, extraocular motility testing, exophthalmometry, pupillometry,and optical coherence tomography imaging. Distillation of the multitudeof ophthalmic functions into a single instrument can allow forcost-savings and for improved clinical efficiency.

In various embodiments, the OCT-based ophthalmic testing center systemcan be configured such that practitioners and/or physicians can orderophthalmic tests a la carte to be performed. In various embodiments, theuser, subject, and/or patient can order and/or perform the ophthalmictests. In various embodiments, the OCT-based ophthalmic testing centersystem can be configured to order ophthalmic tests to be performed on auser, subject, and/or patient. For example, a glaucoma specialist canchoose to order visual acuity testing, extraocular motility testing,corneal pachymetry, gonioscopy, biomicroscopy, pupillometry, andperimetry tests for new patient visits. In various embodiments, theOCT-based ophthalmic testing center system can be configured toadminister a computerized medical history questionnaire, wherein theOCT-based ophthalmic testing center system can be configured to ask thesubject, user, and/or patent a series of general questions and thenfollow-up with additional questions using logical branches to expand onthe patient's responses.

In various embodiments, the OCT-based ophthalmic testing center systemcan comprise software, hardware, and/or logic configured to enable theOCT-based ophthalmic testing center system to conduct and/or dynamicallyconduct ophthalmic tests on users, subjects, and/or patients in responseto historical data, user input/response data, other test data, and/orthe like, or to test subjects, users, and patients in an intelligentmatter. If, for example, the OCT-based ophthalmic testing center systemdetects an abnormal condition during a particular test, the OCT-basedophthalmic testing center system can be configured to automaticallyfollow up with other ophthalmic tests that can provide usefulinformation for making a diagnosis, differential diagnosis, screening,risk assessment, and/or other outputs. In various embodiments, theOCT-based ophthalmic testing center system can be configured toautomatically perform ophthalmic tests based on a patient's personaland/or family medical history and/or other data stored in a databaseassociated with the OCT-based ophthalmic testing center system.

FIG. 28 illustrates various embodiments of an OCT-based ophthalmictesting center system 2800. The OCT-based ophthalmic testing centersystem 2800 comprises a processing unit and/or processor 2812, one ormore display devices 2810, and OCT devices 2816. In various embodiments,the OCT-based ophthalmic testing center 2800 further comprises otherinput/output interface devices 2804, an interpupillary distanceadjustment device 2806, image processing modules 2808, OCT controlmodules and/or OCT data acquisition modules 2814, testing modules 2818,user input devices 2820, and/or data storage mediums 2822. In certainembodiments, the processor or processing unit 2812 comprises a generalor a special purpose microprocessor and/or digital signal processors,and/or the like. The processing unit 2812 can comprise anapplication-specific integrated circuit (ASIC).

In reference to FIG. 28, the display 2810 can be a liquid crystaldisplay (LCD) and/or other display device (for example, as disclosedherein) configured to present images, dots, stimuli, or the like to auser, subject, and/or patient. The display 2810 can be locatedexternally or internally to a main body, or housing, of the OCT-basedophthalmic testing center system 2800. For example, the display devices2810 can comprise display screens located within ocular eyepieces of theOCT-based ophthalmic testing center system 2800. The display devices2810 may comprise one or more light sources, for example, in an emissivedisplay like an array of matrix LEDs. Other types of displays, forexample, LCD, FFD or FLCOS displays can be used. The display devices2810 can display targets of varying shapes and configurations, includinga cross, a bar, alphanumeric characters, and/or one or more dots. Thedisplay devices 2810 can also be configured to display images(stationary or in motion) or movies.

With reference to FIG. 28, the OCT devices 2816 can comprise any of thecomponents and/or features of the OCT systems described herein (forexample, the various embodiments illustrated in FIGS. 1, 3A, 5, 8, 12,21, and/or 26). In various embodiments, the OCT devices 2816 cancomprise, as described herein, an eyepiece for receiving one or botheyes of a user, a light source that outputs light that is directedthrough the eyepiece into the user's eyes, and an interferometerconfigured to produce optical interference using light reflected fromthe user's eyes, and an optical detector disposed so as to detectoptical interference in the user's eyes. In various embodiments, the OCTdevices 2816 can comprise a time domain optical coherence tomographysystem, a frequency domain optical coherence tomography system and/or aswept-source optical coherence tomography system. In variousembodiments, the OCT devices 2816 can comprise a Z-offset adjustmentstage and/or optics as described herein.

In various embodiments, the OCT-based ophthalmic testing center system2800 can be configured to perform manual and/or electronicinterpupillary distance adjustment using the interpupillary distanceadjustment device 2806, as described in more detail herein. Theprocessing unit 2812 can communicate with memory to retrieve and/orstore data and/or program instructions for software and/or hardware. Thememory can include random access memory (“RAM”) for temporary storage ofinformation, a read only memory (“ROM”) for permanent storage ofinformation, and a mass storage device, such as a hard drive, diskette,or optical media storage device. In certain embodiments, the processingunit 2812 is coupled to a network, such as a LAN, WAN, or the Internet,for example, via a wired, wireless, or combination of wired andwireless, communication link as described herein. The networkcommunicates with various computing devices and/or other remoteelectronic devices via wired or wireless communication links.

In various embodiments, the processing unit 2812 is located within theOCT device 2816 itself. In other embodiments, the processing unit 2812is housed within a computing device and/or computer system that iselectrically coupled to and/or in communication with the OCT device2816. In certain embodiments, the processing unit 2812 is connected tothe OCT device 2816 via a wired or wireless network connection or othercommunications medium. The processing unit 2812 can be configured tocommunicate with other remote processing or computing devices via thewired or wireless network connection or other communications medium. Theremote processing or computing devices can include display devices (forexample, a display and/or a monitor), output devices (for example, aprinter or the like), a communications device (for example, a cellphone, PDA, or the like), and/or storage devices (for example, a storagedatabase).

The user input devices 2820 can include tactile input devices, forexample buttons, keyboards or switches, and/or audio input devices, forexample, a microphone. In various embodiments, the tactile and/or audioinput devices can be located on or within the main body of the OCT-basedophthalmic testing center system 2800, and/or can be connected to or incommunication with the OCT-based ophthalmic testing center system 2800.In various embodiments, in which eye tracking is desirable, OCT imagedata can also be used as a functional input by the OCT-based ophthalmictesting center system 2800. In various embodiments in which theOCT-based ophthalmic testing center is operated or controlled by someoneother than the testing subject, an external input device such as akeyboard, mouse, microphone or touch-screen display device, can be usedto control testing, algorithms, processes, protocols and outputs withinthe OCT-based ophthalmic testing center.

In various embodiments, the processing unit 2812 receives user input(for example, button presses, verbal responses) through the user inputdevices 2820. In various embodiments, the processing unit 2812 controlsand transmits output (for example, audio instructions, textualinstructions, light flashes, images, animated content) to the displaydevices 2810 and/or other output interface devices 2804. In variousembodiments, the OCT-based ophthalmic testing center system 2800 can beconfigured to enforce standards of care determined by a physician. Forexample, the OCT-based ophthalmic testing center system 2800 can beconfigured to be programmed to perform ophthalmic tests according to astandard of care schedule prescribed by a physician. In certainembodiments, the OCT-based ophthalmic testing center system 2800 can beprogrammed to operate only after a specified time interval has elapsedsince the last ophthalmic test. Alternatively, the OCT-based ophthalmictesting center system 2800 can be configured to notify the patient viaan alarm, email, or other reminder mechanism when it is time to performanother ophthalmic test. In various embodiments, the OCT-basedophthalmic testing center system 2800 comprises a binocular system (twooptical paths). In various embodiments, the OCT-based ophthalmic testingcenter system 2800 comprises a monocular system (one optical path). Thebinocular system advantageously can perform diagnostic functions thatare either not possible or more difficult to accomplish using amonocular system. The OCT-based ophthalmic testing center system 2800can be configured to be fully automated and self-administered by apatient user, as opposed to a technician, photographer or physician. Incertain embodiments, patients can take OCT-based ophthalmic testingcenter system 2800 to their homes and transmit electronic images oftheir self-administered examination to their physician via acommunications network for an evaluation, risk assessment and/ordiagnosis.

In certain embodiments, the OCT-based ophthalmic testing center system2800 can be configured to output the results of and/or data from thevarious ophthalmic tests to one or more output interface devices 2804 inphysical or remote communication with the OCT-based ophthalmic testingcenter system 2800. The output interface device 2804 may include amonitor screen/display, in which output results are displayed. Theoutput interface device 2804 may include a printer, which prints outputresults. In certain embodiments, the OCT-based ophthalmic testing centersystem 2800 comprises a speaker or headphone jack for providing verbalinstructions and feedback to the user during testing. The outputinterface devices 2804 may be configured to store data on a portablemedium, for example, a compact disc or USB drive or magnetic cardreader, or a portable data storage device. In various embodiments, theOCT-based ophthalmic testing center system 2800 can be configured totransmit output, such as a risk assessment, screening, diagnosis,differential diagnosis, and/or report of data, through a network orcommunications medium. Remote output interface devices can include, forexample, a server, a laptop computer, a cell phone, a smartphone, apersonal digital assistant, a kiosk, or an audio player. For example,the results of self-administered ophthalmic tests can be outputteddirectly to a user, ancillary clinic staff, an ordering physician and/ora clinical trials organization in a hardcopy (for example, printed cardor paper) or electronic format (for example, on a display, via email,text messaged, or in a magnetic strip); stored in local memory on a USBdrive or on an attached computer; transmitted to a central database; ortransmitted directly to the ordering or related physician. In variousembodiments, the OCT-based ophthalmic testing center system 2800comprises a user interface module configured to operate in conjunctionwith input and output devices to allow interaction with a user, asdescribed in detail above. In another embodiment in which the OCT-basedophthalmic testing center system 2800 is operated or controlled bysomeone other than the testing subject, output devices, such as displaydevices or remote devices as described above, can be used to provideinformation during testing that can enable a person other than thetesting subject to control the tests, algorithms, processes, protocolsand outputs during and after a testing session.

In various embodiments, the OCT-based ophthalmic testing center system2800 comprises a tabletop device as illustrated, for example, in FIG.29. For example, the tabletop device can comprise a free-standingstructure similar to a microscope. In various embodiments, the OCT-basedophthalmic testing center system 2800 can comprise a device to be wornby the user like glasses (with earstems supporting the device on top ofeach ear), like goggles (with a strap that extends around the back ofthe head), or like a hat (with a support extending over the top of thehead). Other designs and alternatives of structures to interface withthe user's eyes are possible without departing from the spirit and/orscope of the disclosure.

FIG. 29 illustrates a diagram of one embodiment of a free-standingtabletop device 2900. The tabletop device 2900 includes a base 2902, asupport 2904, a holder 2906, and one or more oculars 2908. Asillustrated, the base 2902 can be configured to rest on a substantiallylevel surface. The support 2904 can be configured to extendsubstantially vertically from the base 2902. In certain embodiments, thesupport 2904 can be configured to be height-adjustable. The holder 2906is configured to retain the oculars 2908. The holder 2906 can beconfigured to be rotated with respect to the longitudinal axis of thesupport to allow for a comfortable viewing angle. The holder 2906 caninclude a locking mechanism configured to fix the rotation of the holder2906 once the holder 2906 has been rotated to the desired position. Theholder 2906 can be configured to slidably retain the oculars 2908. Forexample, the oculars 2908 can be configured to slide in and out of theholder 2906. The holder 2906 and/or the oculars 2908 can includesuitable mechanisms for locking the oculars 2908 with respect to theholder 2906 after proper adjustment. For example, the locking mechanismscan include a détente, a clamp or the like.

FIGS. 30A-30E illustrate various alternative embodiments of basedesigns. In certain embodiments, the base 3002 comprises a flat baseformed of a solid and/or heavy material configured to prevent the OCTdevice from tipping over (as illustrated, for example, in FIG. 30A). Invarious embodiments, the base 3002 comprises a tripod mechanism (asillustrated, for example, in FIG. 30B). In various embodiments, the base3002 comprises a clamp-on or screw-mounted base configured to secure theOCT device to a tabletop or other substantially level surface (asillustrated in FIGS. 30C and 30D, respectively). In yet otherembodiments, the base 3002 comprises an ergonomic lap support (asillustrated in FIG. 30E). It should be appreciated that other basedesigns are possible without departing from the spirit and/or scope ofthe disclosure.

In various alternative embodiments, the oculars 2908 comprise one ocularor two oculars. In various embodiments, the ocular interface of theoculars 2908, which is the portion of the OCT device that contacts theuser's eyes, comprises an integrated, one-piece design (as illustratedby the ocular interface 3008 of the handheld device in FIG. 30F) asopposed to a dual-barrel design. The corresponding disposable hygienicbarrier can also comprise a one-piece design to conform with the ocularand/or forehead interface. In certain embodiments, the oculars 2908comprise an auto-focus lens system guided by software modules orroutines that automatically adjust for refractive errors to provideclearer OCT images.

In certain embodiments, the OCT-based ophthalmic testing center system2800 comprises a handheld device to be supported by the user (similar toa pair of binoculars or a telescope) as illustrated, for example, inFIG. 30F. In certain embodiments, the internal interpupillary distanceadjustment device 2806 of the OCT-based ophthalmic testing center system2800 can comprise an internal interpupillary distance adjustment devicethat can be controlled using an electric motor that can be adjusted, forexample, by centering B-scans through the pupils, as described herein.In various embodiments, the internal interpupillary distance adjustmentdevice 2806 can be mechanically controlled and/or adjusted using aninterpupillary distance adjustment device as described herein. Invarious embodiments, interpupillary adjustments can be conducted in twoaxes, horizontal and vertical. In various embodiments, the handhelddevice can be configured to connect to a hygienic barrier that caneither be a one-piece or two ocular pieces as described herein.

As discussed herein, in various embodiments, the OCT-based ophthalmictesting center system can be configured to detect, measure a widevariety of other conditions and/or characteristics of the eye, includingbut not limited to the location of the fovea and/or other fixationtargets/structures in the eye, extraocular motility, response of thepupils to stimuli, depth of the eye, visual acuity, contrastsensitivity, peripheral vision, topographies, thicknesses, distances,angles, distortions perceived by the eye, reading speed, stereoacuity,degrees of foveal suppression, and refractive errors. The OCT-basedophthalmic testing center system can be configured to perform a varietyof ophthalmic tests (for example, via execution of the testing modules2818) including but not limited to refractive error testing, gazedetection, for example, through iris plane analysis and/or pupillaryanalysis, foveal/fixation verification, foveal/fixation location,biomicroscopy, extraocular motility testing, pupillometry testing,exophthalmometry testing, visual acuity testing, contrast sensitivitytesting, fixation stability testing, perimetry testing (confrontationand/or kinetic and/or static), corneal topography testing, cornealpachymetry testing, visual gonioscopy testing, color vision testing,distortion testing, reading speed testing, stereoacuity testing, fovealsuppression testing, and any other ophthalmic testing.

Refractive Error Correction

In addition to improving the image produced by the OCT system, theautofocus system can also provide an output corresponding to refractiveerror correction for the eye. Determining the refractive error of theeye using the OCT signal has been described above. Accordingly, theOCT-based ophthalmic testing center system can output refractive error,for example, sphere and astigmatism, or may output that one or moreconditions, such as anisometropia or largely unequal refractive errorsthat can lead to amblyopia, has been detected.

As described above, in various embodiments, the Z-offset used toidentify the distance to the cornea and/or the retina can be employed inconjunction with the auto-focus to arrive at an appropriate value ofspherical power correction for the patient or user.

FIG. 31 shows an example of an emmetropic eye 3110. The object is atinfinity. In various embodiments, the probe beam and the object are bothsubstantially collimated. FIG. 31 shows a lens system 3130, which mayinclude the autofocus optics, set to provide a collimated beam incidenton the eye 3110. Because the eye 3110 is emmetropic, the collimated beamis focused on the retina 3140. As described above, the OCT signal can bemonitored (while adjusting the Z-offset) to set the OCT instrument 3120to probe the retina 3140 (for example, by identifying a peak in the scanof the OCT signal, which is increased for the reflective tissue of theretina 3140). Additionally, the auto-focus can be adjusted todemonstrate that the OCT signal is peaked when the auto-focus isconfigured to provide a collimated beam. Since the lens system 3130 isadjusted to provide a collimated beam, and the beam is determined to befocused on the retina 3140, the eye 3110 is identified as emmetropic. Inanother embodiment, lenses to correct for astigmatic error can beinserted into the lens system 3130 and adjusted to increase or maximizethe OCT signal from the retina 3140 in the same manner as auto-focus.

Another framework for determining the refractive correction, which is 0D in this case, is to consider the vergence of the beam upon entry intothe eye 3110. As described above, when the beam of light is focused onthe retina 3140, the vergence of the light entering the cornea 3150 isessentially counteracted to focus on the retina 3140. This vergence oflight entering the cornea 3150 is therefore a very close approximationto the spherical equivalent refractive error in the eye 3110.Accordingly, if the lens system 3130 is adjusted so that the probe beam(and/or the fixation target) is focused on the retina 3140, vergence oflight entering the cornea 3150 can be determined to obtain an estimateof the refractive correction of the eye 3110. In the example shown inFIG. 32B, the lens system 3230 is adjusted so that the beam iscollimated. The vergence of the light entering the cornea 3250 is 0 D(regardless of the distance to the cornea 3250). Accordingly, therefractive error is 0 D.

FIGS. 32A and 32B show an example of a myopic eye 3210. In this example,the object is generally at infinity. In FIG. 32A, the lens system 3230is set such that the beam incident on the cornea 3250 is collimated.However, because the eye 3210 is myopic, the beam comes to a focus priorto reaching the retina 3240.

FIG. 32B shows the lens system 3230, which may include the autofocusoptics, adjusted to focus the beam (target and probe beam) on the retina3240. As described above, the OCT signal can be monitored (whileadjusting Z offset) to set the OCT instrument 3220 to probe the retina3240 (for example, by identifying a peak in the scan of the OCT signal,which is increased for the reflective tissue of the retina 3240).Additionally, the auto-focus can be adjusted such that the OCT signal ispeaked, wherein presumably the OCT instrument 3220 is optimally focusedon the retina 3240. In another embodiment, lenses to correct forastigmatic error can be inserted into the lens system 3230 and adjustedto substantially increase, identify a peak in, or substantially maximizethe OCT signal from the retina 3240 in the same manner as auto-focus.

With the auto-focus set such that the OCT instrument 3220 is focused onthe retina 3240, the auto-focus setting can be used to determine therefractive error in the eye 3210 causing the eye 3210 to be myopic.

For example, the position of the auto-focus lens system 3230 can be usedto determine the vergence of light exiting the lens system 3230.Additionally, the distance to the cornea 3250 can be obtained using aseparate measurement, for example, the Z-offset to the cornea or refinedanterior corneal boundary as discussed previously. The distance to thecornea 3250 can be employed to determine the vergence of the light as ithits the cornea 3250.

As described above, when the OCT instrument 3220 is optimally focused onthe retina 3240, the vergence of light entering the cornea 3250 isessentially counteracted to focus on the retina 3240. This vergence oflight entering the cornea 3250 is therefore a very close approximationto the spherical equivalent refractive error in the eye 3210.Accordingly, if the lens system 3230 is adjusted so that the probe beam(and/or the fixation target) is focused on the retina 3240, the vergenceof light entering the cornea 3250 can be determined to obtain anestimate of the refractive correction of the eye 3210. In the exampleshown in FIG. 32B, the vergence of the beam upon entry into the eye3210, determined based on the vergence of light exiting the lens system3230 and the distance of the lens system 3230 to the cornea 3250, is−4.0 D. Accordingly, the refractive error of the eye 3210 can beestimated to be about −4.0 D.

FIGS. 33A and 33B show an example of a hyperopic eye 3310. In thisexample, the object is generally at infinity. In FIG. 33A, the lenssystem 3330 is set such that the beam incident on the cornea 3350 iscollimated. However, because the eye 3310 is hyperopic, the beam comesto a focus beyond the retina 3340.

FIG. 33B shows the lens system 3330, which may include the auto-focusoptics and/or optics to correct for astigmatic error, adjusted to focusthe beam (target and probe beam) on the retina 3340. As described above,the OCT signal can be monitored (while adjusting the z-offset) to setthe OCT instrument 3320 to probe the retina 3340 (for example, byidentifying a peak in the scan the OCT signal, which is increased forthe reflective tissue of the retina 3340). Additionally, the auto-focuscan be adjusted such that the OCT signal is peaked, wherein presumablythe OCT instrument 3320 is optimally focused on the retina 3340. Inanother embodiment, lenses to correct for astigmatic error can beinserted into the lens system 3330 and adjusted to substantiallyincrease, identify a peak in, or substantially maximize the OCT signalfrom the retina 3340 in the same manner as auto-focus.

With the auto-focus set such that the OCT instrument 3320 is focused onthe retina 3340, the auto-focus setting can be used to determine therefractive error in the eye 3310 causing the eye 3310 to be hyperopic.

For example, the position of the auto-focus lens system 3330 can be usedto determine the vergence of light exiting the lens system 3330.Additionally, the distance to the cornea 3350 can be obtained using in aseparate measurement, for example, the Z-offset to the cornea or refinedanterior corneal boundary as discussed previously. The distance to thecornea 3350 can be employed to determine the vergence of the light as ithits the cornea 3350.

As described above, when the OCT instrument 3320 is optimally focused onthe retina 3340, the vergence of light entering the cornea 3350 isessentially counteracted to focus on the retina 3340. This vergence oflight entering the cornea 3350 is therefore a very close approximationto the spherical equivalent refractive error in the eye 3310.Accordingly, if the lens system 3330 is adjusted so that the probe beam(and/or the fixation target) is focused on the retina 3340, the vergenceof light entering the cornea 3350 can be determined to obtain anestimate of the refractive correction of the eye 3310. In the exampleshown in FIG. 33B, the vergence at the eye 3310, determined based on thevergence of beam exiting the lens system 3330 and the distance of thelens system 3330 to the cornea 3350, is +1.0 D. Accordingly, therefractive error can be estimated to be about +1.0 D.

The object need not be set at infinity. In certain embodiments, forexample, measurements of refractive error as the distance to thefixation targets is changed can be used to estimate the accommodativeamplitude. For example, if no refractive error is found to exist whenthe fixation target is at infinity (collimated light), while refractiveerror is measured when the fixation targets are closer to the eye 3310,the eye 3310 may be accommodative.

FIGS. 34A and 34B show an example of an eye 3410 with presbyopia. Inthis example, the object is generally near. As described above, opticsmay be included between the fixation target display and the eye 3410 todiverge the beam and simulate a target that is near. In someembodiments, the target distance is set to be at 3414 inches (typicalreading distance) or possibly 3430 inches (typical computer viewingdistance), although other values are possible. Accordingly, in FIG. 34A,the lens system 3430 is adjusted such that target that is near. However,because the eye 3410 exhibits presbyopia, the beam comes to a focusbeyond the retina 3440.

FIG. 34B shows the lens system 3430, which may include the auto-focusoptics and/or optics to correct for astigmatic error, adjusted to focusthe beam on the retina 3440. As described above, the OCT signal can bemonitored (while adjusting the z-offset) to set the OCT instrument 3420to probe the retina 3440 (for example, by identifying a peak in the scanthe OCT signal, which is increased for the reflective tissue of theretina 3440). Additionally, the auto-focus can be adjusted such that theOCT signal is peaked, wherein presumably the OCT instrument 3420 isoptimally focused on the retina 3440. The adjustment of the autofocusoptics that produces a focused beam on the retina 3440 provides anestimate of the add power used to correct the presbyopia for a nearfixation target at the distance specified above, and thus the refractiveerror of the eye 3410.

Variations in the methodology for measuring refractive error as well asthe system design are possible.

Eye Tracking

In certain embodiments, the OCT-based ophthalmic testing center systemcan be configured to perform automatic eye tracking or fixationmonitoring during the various structural and functional ophthalmictests. In various embodiments, the OCT-based ophthalmic testing centersystem can be configured to perform eye tracking based on OCT imagingmodalities, non-OCT imaging modalities, or a combination of both. Ingeneral, OCT images contain information about unique eye structures, forexample, the pupil, anterior segment, fovea, retinal vessels or opticnerve, and high speed OCT scans can be used to track the movement of thepupil, anterior segment, fovea, retinal vessels and/or other fundusstructures to be used as an objective functional input when no verbal ormanual input is desired. The functional input can be used to provideconfidence to a physician that the data and/or results of the ophthalmictests are accurate and reliable. In certain embodiments, eye tracking isperformed in real-time during testing. Real-time eye tracking canprovide automatic, objective feedback to the OCT-based ophthalmictesting center system and allow the test to be modified in real-time.For example, if the ophthalmic testing center system determines that asubject is not gazing in the right direction during testing, the subjectcan be given instructions to conform to the testing protocol. In variousembodiments, eye tracking is performed after testing during apost-processing phase. Post-processing eye tracking can be used toquantify data/results and/or remove unreliable data/results. In certainembodiments, the OCT-based ophthalmic testing center system can beconfigured to rerun an ophthalmic test based on the results of apost-processing eye tracking analysis. As described in further detailbelow, eye tracking can be performed during various ophthalmic testsusing OCT data to assist in determining the function of the eye.

With reference to FIG. 35A and FIG. 35B, the ophthalmic testing centercan be configured to perform eye tracking or fixation monitoring duringvarious ophthalmic tests by performing iris plane analyses, pupillaryanalyses, or anterior chamber analyses. For example, iris plane analysisis the process of determining the planar configuration, direction, tiltand/or slope of the iris tissue 3504A. When an eye changes it fixationand/or gaze to look in a new direction, the slope of the iris plane3504A containing the pupil changes in a similar manner to a satellitedish pointing in a new direction. In various embodiments, the tilt orslope of the iris plane 3504A can be determined by performing opticalcoherence tomography A-scans, B-scans and/or 3D-OCT scans 3502A of theanterior chamber and/or iris, and can include the angle, the corneaand/or the lens, as discussed below in the gonioscopy test. Generallythe plane of the iris 3504A may not be regular or perpendicular to thecentral axis of the eye. To account for this, in various embodiments,the starting plane of an iris 3504A is determined during foveal fixationin an eye prior to gaze tracking. In various embodiments, the changes inthe tilt or slope of the iris plane can be determined as differencesfrom this starting plane. In various embodiments, errors in irisdetection can be handled by fitting all detected iris plane locations toa linear regression formula to approximate a straight plane through theiris 3504A. This can have the effect of accounting for and/or ignoringoutlying errors that do not fit with the other detected points. Othermethodologies for determining the plane of the iris are possible, forexample, RANSAC (Random Sample Consensus). The foregoing is similarlyapplicable to pupillary analyses, and/or anterior chamber analyses.

In reference to FIG. 35A and FIG. 35B, in various embodiments, A-scans3502A are collected more toward the periphery of the iris and/or corneabecause generally little iris tissue exists in the pupil region. Thiscan also allow for easier change detection because the differences atthe extreme distances from the center of the eye due to changes in gazedirection will generally be larger than differences in the central ofthe eye; however, the OCT-based ophthalmic testing center can beconfigured to detect change by collecting A-scans toward the center ofthe eye. In various embodiments, A-scans are more evenly distributedacross the anterior segment. Other data collection configurations arepossible. OCT A-scans acquired from the anterior segment are analyzed bya processor, which can use image analysis routines, for example, edgedetection, to identify the interface between the anterior chamber fluidand the iris tissue. This boundary can constitute the iris plane. Asdiscussed previously, a plane fit to these data points with linearregression can be compared to a similar plane fit captured as areference scan. In various embodiments, anterior chamber analysis can beused to augment these measurements and/or provide additional informationon gaze direction.

With reference to FIG. 35A and FIG. 35B, in various embodiments, A-scansare collected in a radial line pattern centered on the optical axis ofthe instrument ocular. Individual A-scans can be analyzed with anattached processor using image processing algorithms, for example, edgedetection, to determine the anterior border of the iris tissue, ifpresent. In each radial line B-scan, a central block of A-scans notcontaining iris tissue can represent the pupil. Using the foregoing, thepupil margin can be detected for all radial line scans, and/or theborder delineated for 360 degrees, and/or the roundness 3502B of thepupil analyzed to determine the direction of gaze.

The ophthalmic testing center system can be configured to perform eyetracking or fixation monitoring during various ophthalmic tests byperforming foveal verification, or foveal detection, and/or foveallocation. Foveal verification is the process of verifying that the foveaor “best fixating retina” is present in an expected location. In otherwords, foveal verification can be used to double-check that a testsubject is looking where they are expected to look. Foveal verificationcan be performed during functional tests that instruct the subject tofollow fixation targets on a display screen to ensure that the subjectcomplies with the instructions, such as perimetry tests, extraocularmotility tests, and visual acuity tests. In certain embodiments, if thesubject has been instructed to look at a fixation target, the expectedlocation of the fovea would be at a location on the retina correspondingto the opposite end of an optical projection axis extending from thefixation target back to the retina. For example, if the subject issupposed to be gazing at a fixation target in the upper right corner ofa display screen, then the expected foveal location would be at a lowerleft region of the retina. In certain embodiments, the ophthalmictesting center system can determine the optical axial length of the eyeto aid in foveal verification.

With reference to FIG. 35C, in certain embodiments, the OCT-basedophthalmic testing center system can be configured to acquire a small3D-OCT scan 3505 (for example, 100×100 A-scans or 50×50 A-scans), of asmall area (for example, 1×1 mm) around the expected location of a foveaon a retina 3507. The acquisition of the small 3D-OCT scan could occurrepeatedly at high speeds, for example, at least every second, every 100milliseconds, every 25 milliseconds, every 10 milliseconds, or any othernumber of seconds, or only a single time. In certain embodiments, theOCT-based ophthalmic testing center system can be configured to detectthe interface between the vitreous and retina/nerve fiber layer (the “VRinterface”) for each of the A-scans in the small 3D-OCT dataset usingedge detection routines. The OCT-based ophthalmic testing center systemcan then be configured to form a 2D map 3506 of scalar values of thedistance to, or depth of, the VR interface for each of the A-scans. Incertain embodiments, the fovea or optic nerve, if present, can bedetected from this map as the most extreme (either largest or smallest)value in the set. With reference to FIG. 35C, the fovea can beidentified as the brightest area 3508 of the 2D map 3506.

In another example, the inner retina can be detected using edgedetection methods and fit to a polynomial curve. The substantiallymaximal foveal depression can be detected as the substantially maximaledge-detected deviation downward from this polynomial curve. In variousembodiments, the degree of confidence in foveal detection can bemeasured as the deviation from the polynomial curve. Alternatively,since the outer nuclear layer comprises nearly 100% of the retinathickness in the foveola, the fovea can be detected by looking for thearea with nearly 100% outer nuclear layer composition to the retina.Other ways in which the fovea can be detected are to look for focallyincreased thickness of the photoreceptor outer segments, substantiallymaximal separation of thick nerve fiber layer and location of a brightfoveal reflex at the vitreoretinal interface.

In another embodiment, the OCT-based ophthalmic testing center systemcan be configured to detect the interface between retina and the retinalpigment epithelium (the “RR” interface) for each of the A-scans in thesmall 3D-OCT dataset using edge detection routines. The presence ofbreaks or discontinuities in this “RR” interface can be used to indicatethe presence of retinal vessels which are substantially absent from thefovea. Therefore, an absence of “RR” discontinuities can be used as apositive indicator of foveal presence. Conversely, presence of “RR”discontinuities can be used as an indicator that the fovea is absentfrom the imaged region. In still another embodiment, the OCT-basedophthalmic testing center system can be configured to form a 2D map ofscalar values of the difference between the VR and RR interfaces, alsoknown as the retinal thickness, for each of the A-scans.

In various embodiments, the 2D map of scalar values can be converted toa slope, or first derivative, map that can be registered to other 2Dslope maps with registration routines, such as Scale Invariant FeatureTransform (“SIFT”) or cross-correlation. The slope maps and registrationroutines can advantageously be used to indicate the point of maximum orpreferred retinal fixation for eyes that don't have normal fovealdepressions. For example, the slope map and registration routines can beused for subjects having a protrusion from retinal thickening instead ofa normal foveal depression. In certain embodiments, the OCT-basedophthalmic testing center system can be configured to acquire a smallreference image of the expected foveal location at a point of preferredfixation during testing. For example, the point of preferred fixationcan occur during visual acuity testing when the subject is instructed tolook straight ahead. The reference image can be used as the “bestfixating retina” for subsequent fixation monitoring. In certainembodiments, the reference image can be stored by the OCT-basedophthalmic testing center system for subsequent comparison andreference.

In certain embodiments, the OCT-based ophthalmic testing center systemcan be configured to perform foveal verification using non-OCTmodalities. For example, the OCT-based ophthalmic testing center systemcan be configured to acquire fundus images using infrared or scanninglaser ophthalmoscopy (“SLO”) imaging. An exemplary SLO image 3510 of a6×6 mm retinal area is illustrated in FIG. 35C. The fovea can beidentified as present in the non-OCT images by the point/region ofmaximal fundus pigmentation 3512. Alternatively, the fundus images canbe registered to previous non-OCT images, such as a reference imageobtained during preferred fixation, to use for comparison by sum ofsquared differences or SIFT registration.

With reference to FIG. 36, foveal location can be performed by theOCT-based ophthalmic testing center system when no prior information isknown about the foveal location and/or when foveal verification testingfails. For example, foveal location can be performed during extraocularmotility testing to determine a quantifiable measurement of a deficiencyin extraocular movement when the fovea is not found to be directed atthe fixation target. In conducting foveal location, the OCT-basedophthalmic testing center system can be configured to acquire a set ofA-scans (such as hundreds or thousands) in a sparse pattern (such atleast as every 50 microns, every 100 microns, or every 200 microns)across a two-dimensional fundus field at high speeds (such as every10-20 ms). With reference to FIG. 36, each of the small circles 3602 onthe illustrated fundus image 3604 represents an individual A-scan. Incertain embodiments, the fundus field 3604 can comprise a field in therange of 3×3 mm to 15×15 mm. For example, the set of A-scans cancomprise 625 or 2400 individual A-scans across a 6×6 mm field. TheOCT-based ophthalmic testing center system can be configured to compilethe sparsely-placed individual A-scans into a long B-scan of the fundusfield. FIG. 36 illustrates a portion of a B-scan 3606 generated from theset of A-scans (represented by circles 3602). In certain embodiments, afoveal depression can be identified as the region having the lowestprofile on the B-scan (identified by arrow 3608 on the partial B-scan3606). In another embodiment, the section of a similar long B-scanidentifying the “best fixating retina,” as described previously, couldbe matched or registered to this long B-scan to identify the location ofthe best fixating retina in the current long B-scan.

In various embodiments, as described above in connection with fovealverification, the OCT-based ophthalmic testing center system can beconfigured to identify a foveal location by performing edge detection ofthe VR interface for each of the A-scans in the sparse 3D-OCT dataset orby creating a slope (derivative) map 3610. The area of the VR interfacehaving the greatest slope (corresponding to the lightest area on theslope map 3610) indicates the location of the fovea.

With reference to FIG. 37, as described above, in certain embodiments,the OCT-based ophthalmic testing center system can be configured to usenon-OCT imaging modalities to track the fovea and retina. For example,non-OCT imaging modalities such as infrared or SLO imaging can acquirefundus images without pupillary dilation. In certain embodiments, theinformation from the fundus images can be used as a functional input tothe OCT-based ophthalmic testing center system. In certain embodiments,(for example, where the fovea is normal and disease free) the foveallocation can be detected as the point/region of maximal funduspigmentation (identified as the darkest areas in the first SLO image3702 and the second SLO image 3704 and pointed to by arrows). In variousembodiments, (for example, where the fovea is not well-defined), theOCT-based ophthalmic testing center system can be configured to analyzethe relative eye movement between the first SLO image 3702 and thesecond SLO image 3704 in order to track the foveae. For example, thesecond SLO image 3704 can be registered to the first SLO image 3702, oreach of the first and second SLO images 3702, 3704 can be registered toa reference image obtained during a point of preferred fixation duringtesting using cross-correlation, sum of squared differences or SIFTregistration.

OCT Biomicroscopy

With reference to FIG. 38, optical coherence tomography (“OCT”)instruments provide magnified, cross-sectional views of transparenttissues in the eye. In general, OCT biomicroscopy (“OBM”) comprisesscanning and imaging of the transparent tissues of the eye in order toprovide a structural analysis. OBM scans advantageously provideobjective, documented, reproducible, standardized, and quantifiableresults. In certain embodiments, the OCT-based ophthalmic testing centersystem can be configured to generate OBM images of various regions ofthe eye. For example, the OCT-based ophthalmic testing center system canbe configured to generate OBM images of all or substantially all of theeye tissues along the central axis (for example, optical axis) of theeye from the pre-cornea to the choroid. In various embodiments, theOCT-based ophthalmic testing center system can be configured to imagethe front of the eye (for example, the pre-cornea, the cornea, theanterior chamber, the anterior chamber angle, and the iris) and the backof the eye (for example, the retina, choroid, and the optic nerve) atthe same time. In certain embodiments, the OCT-based ophthalmic testingcenter system can be configured to scan at least the entire central axisof the eye from front to back. The scan of the central axis of the eyecan include imaging the panaxial tissues of the eye. In certainembodiments, the OCT-based ophthalmic testing center system can beconfigured to scan the eye, including tissues from the front to theback, in either a side-to-side pattern, in a top-to-bottom pattern, orin a front to back pattern. In certain embodiments, OBM isadvantageously more objective, documented, detailed, consistent andquantitative than slit lamp biomicroscopy.

OBM can be performed on children or adults. For example, OBM can beperformed on children to detect anterior chamber inflammation and/orcystoid macular edema associated with Juvenile Rheumatoid Arthritis. Asanother example, OBM can be performed on adults to detect narrow angleglaucoma by assessing their angle geometry and anterior chamber depth,as well as optic disc cupping due to optic nerve damage from theglaucoma. In various embodiments, the OCT-based testing center systemcan be configured to conduct OBM in either a self-operated orself-administered fashion, or in an assisted fashion with someone otherthan the subject either partially or completely administering the test.The OBM test can be performed on both eyes simultaneously or first onone eye and then on the other eye.

The OCT-based ophthalmic testing center system can be configured toperform OBM scans on an anterior region of the eye (for example, using3D raster scans or radially oriented B-scans) to detect and quantifyophthalmic conditions in the cornea, anterior chamber and angle, such askeratic precipitates, anterior chamber cell or flare, or irisneovascularization (with the aid of Doppler OCT). OBM scans of thecrystalline lens can enable more objective assessments of cataractprogression (for example, by monitoring the lens thickness and curvatureor by comparing lens opacity and reflectivity between scans). OBM scanscan also be used to quantify axial length measurements and monitorposterior capsular opacification and post-operative intraocular lensposition.

In certain embodiments, OBM scans can be used to image the entirevitreous cavity, thereby enabling more objective and automatedquantification of vitreous pathology, such as vitritis and vitreoushemorrhage. OBM scans of the entire axial vitreous cavity can also aidin detecting peripheral lesions, posterior vitreous detachments,vitreoretinal interface disorders and/or the like. OBM scans of theposterior retinal region can be used to detect subretinal fluid, drusen,retinal pigment epithelial detachments, and/or geographic atrophy. OBMscans of the choroid region can advantageously aid in the diagnosis andmonitoring of central serous choroidopathy and age-related maculardegeneration.

In certain embodiments, the OCT-based ophthalmic testing center systemcan comprise display devices configured to present stationary fixationtargets to the user, such as dots, crosses, circles or images. Invarious embodiments, the OCT-based ophthalmic testing center system canbe configured to present animated or transient targets, such as movies,to the user. In certain embodiments, the OCT-based ophthalmic testingcenter system can be configured to instruct the user (visually and/oraudibly) to look straight ahead at the fixation targets throughout theexamination. In various embodiments, OBM, as a structural analysis, doesnot employ eye tracking modalities. Tissues included in the OBM scanscould include, but would not be limited to, the eyelids and lid margins,precorneal structures (including the tear film and contact lenses), theconjunctiva, the cornea, angle structures, the anterior chamber, theiris, the lens and capsule, the vitreous, the retina, the retinalpigment epithelium, the optic nerve, the choroid and the sclera.

Imaging from the front to the back of the eye can be accomplished inseveral ways. With continued reference to FIG. 38, in certainembodiments, the OCT-based ophthalmic testing center system can beconfigured to scan the entire depth of the eye (e.g., at least 30 mm, 35mm or 40 mm) in a single A-scan, B-scan and/or 3D-OCT scan 3802 using aninstrument having a suitable light source and sufficient depth of fieldor focus. In various embodiments, the B-scans and/or the 3D-OCT scanscomprise A-scans that are generated by using the OCT-based ophthalmictesting center system that scans the entire depth or substantially theentire depth of the eye in a single scan. For example, in variousembodiments, a “scout” scan, similar to high-speed, substantiallyfull-body scans performed prior to computed tomography or magneticresonance imaging of the human body, can be acquired by combining afirst B-scan (or set of laterally displaced B-scans) with the Fourierdomain zero delay position set anteriorly with a second B-scan (or setof lateral displaced B-scans) with the Fourier domain zero delayposition set posteriorly using a mathematical operator, such as alogical OR operator, to generate a single result OCT image. (In someembodiments, the first B-scan and the second B-scan are derived fromdata obtained using a single OCT scan extending from an anterior regionto a posterior region of the eye but are processed using differentFourier domain zero delay positions.) This image can have highsensitivity anteriorly and high sensitivity posteriorly to enablemeasurements, such as the axial length, from the anterior cornea to theposterior retina, of an eye. In various embodiments, the position of theanterior corneal surface can be estimated using normative data ordetected using OCT imaging of the cornea as described previously. Theinitial B-scan depth can be set at a predefined value, such as 35 mm,that is longer than most human eyes. A procedure can then be used toshorten this anticipated length progressively by increments, such as 2mm, until the posterior border of the retina is visualized. The distancebetween the anterior corneal surface and the posterior retinal surfacecan be used as the axial length of the eye and subdivided into sectionsfor progressive B-scan imaging of panaxial tissues as described below.In various embodiments, the OCT-based ophthalmic testing center systemcan be configured to generate A-scans, B-scans, and/or 3-D scans usingscanning that are not scout scans but that comprise a single scan of theentire or substantially entire depth of the eye. Eyes vary in depthdepending on the subject, but may range, e.g., from at least 18 mm, 20mm, 30 mm, 35 mm or 40 mm but may have other depths. Measurements may beperformed on these scans and/or images or information may otherwise beextracted from these scans to perform various ophthalmic tests (e.g.,functional and/or structural) disclosed herein.

In certain embodiments, the OCT-based ophthalmic testing center systemcomprises a variable focus system with a wide range of focus depth, suchthat the focal point is capable of simultaneously focusing, for example,on the retina and the cornea.

In various embodiments, raster (3D) scans or radial line B-scans ofvariable depth (for example, 2 mm, 4 mm or 5 mm thick, or larger orsmaller), can be captured sequentially from the front to the back of theeye using a programmatic approach. For example, a plurality 3D-OCT scans(formed by rastering laterally in orthogonal x and y directions) havinga thickness of 2 mm can be arranged or stacked longitudinally along anaxis of the eye, one 3D-OCT scan in front of another so as to form alarger 3D-OCT scan having a depth greater than 2 mm thick, e.g., atleast 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36,38, 40 mm. The axis may be parallel to the optical axis of the eye incertain embodiments. The plurality of 3D-OCT scans arranged one in frontof the other may produce a resultant 3D-OCT scan that extends from ananterior structure of the eye, e.g., cornea, to a posterior structure ofthe eye, such as the retina, and may include an intermediate structuresuch as the vitreous. Smaller 3D-OCT scans may extend from an anteriorstructure (e.g., cornea) to an intermediate structure (e.g. vitreous) orfrom an intermediate structure to a posterior structure (e.g., retina).Similarly, a plurality of B-scans that have a thickness of 2 mm can bearranged or stacked longitudinally along an axis of the eye, one B-scanin front of another, so as to form a larger B-scan having a depthgreater than 2 mm thick, e.g., at least 4, 6, 8, 10, 12, 14, 16, 18, 20,22, 24, 26, 28, 30, 32, 34, 36, 38, 40 mm. The scans arranged one infront of the other may or may not overlap each other and may or may notbe spaced apart by gaps. The location of the scan along the longitudinalaxis may be controlled by the Z-offset. Translating the Z-offset mirror,for example, varies the depth within the eye which is imaged.Accordingly, to obtain a plurality of scans at different depths, theZ-offset can be suitably adjusted for each scan. The focus may similarlybe adjusted to increase image quality, especially if the depth of focusof the focusing optics is small.

FIG. 38 illustrates a simulated OBM image 3804 generated by stackingmultiple 3D-OCT scans sequentially along an axis of the eye and avirtual representation of an OBM image 3806 illustrating the variabledepth scans. In some embodiments, the OCT-based ophthalmic testingcenter system can be configured to montage the multiple sequential axial3D scans or B-scans together either with or without axial overlap. FIG.38 also illustrates a demonstrative virtual representation of an OBMimage with axial overlap 3808. The longitudinal array of scans togetherproduce an aggregate scan that spans a larger longitudinal distancealong the axis, e.g. optical axis of the eye.

As described above, a plurality of 3D OCT scans or B-scans can beobtained at different depths into the eye so as to produce an aggregateOCT scan that extends over the longitudinal thickness of the eye. Forexample, ten to twenty OCT scans 2 mm thick can be used to produce anOCT scan 20-40 mm thick. Controlling the depths at which the differentscans are obtained, and consequently any overlap or spacing betweenadjacent scans, affects the overall longitudinal thickness of theresultant scan. Similarly, the thickness of each of the plurality ofscans affects the overall longitudinal thickness of the resultant scan.Accordingly, to include pre-corneal tissue as well as scleral tissue ina scan, formed by a plurality of longitudinally displaced scans, willinvolve less scans if the scans are thicker and more scans if the scansare thinner. The thickness of the each of the scans arranged or montagedto form the larger scan need not be the same.

In various embodiments, the OCT-based ophthalmic testing center systemcan be configured to programmatically capture sequential 3D scans orB-scans in such a way as to reduce, minimize, or remove the mirror imageartifact around the zero delay point that exists with Fourier domainOCT. As is well known, a ghost image may be introduced as a result ofthe folding of scan data about the zero delay point in Fourier domainOCT. This ghost image may be an inverted image of nearby tissue. In thecase where OCT scanning extends through the anterior chamber, thevitreous chamber, and the posterior chamber, ghost images of theanterior or posterior chamber may be superimposed on the image of thevitreous chamber. These ghost images may be inverted images of, forexample, the iris or retina, or other structure features.

Various techniques may be used to reduce the effect of the mirror imageartifact resulting from folding of scan data about the zero delay pointin Fourier domain OCT. Phase-shifting the signal using electro-opticmodulators, acousto-optic frequency modulators, piezo transducers, aswell as employing small beam offsets at the fast-scanning mirrors arepossible. See, for example:

-   Zhang J, Jung W, Nelson J S, Chen, Z. Full range    polarization-sensitive Fourier domain optical coherence tomography.    Optics Express. November 2004. 12(24):6033-6039.-   Bachmann A. Leitgeb R A, Lasser T. Heterodyne Fourier domain optical    coherence tomography for full range probing with high axial    resolution. Optics Express. February 2006. 14(4):1487-1496.-   Bu P, Wang Z, Sasaki O. Full-range parallel Fourier domain optical    coherence tomography using sinusoidal phase-modulating    interferometry. J. Opt A: Pure Appl. Opt. 9 (2007) 422-426.-   Vakhtin A B, Peterson K A, Kane D J. Demonstration of    complex-conjugate-resolved harmonic Fourier-domain optical coherence    tomography imaging of biological samples. Applied Optics. June 2007.    46(18):3870-3877.-   Yasuno Y, Makita S, Endo T, Aoki G, Sumumura H, Itoh M, Yatagai T.    One-shot-phase-shifting Fourier domain optical coherence tomography    by reference wavefront tilting. Optics Express. 2004.    12(25):6184-6191.

Additionally, image processing techniques can be employed. In variousembodiments, for example, two images of the same tissue can be combinedusing an AND logical operator to preserve or reinforce the real tissuesignal while removing, or at least attenuating the ghost image. The twoimages may, for example, correspond to two scans of the same tissuecaptured with different zero delay points. One scan may be completedwith a zero delay point on the top of the scan and another scan may becompleted with the zero delay point on the bottom of the scan. Adifferent ghost image will accompany each of the two scans since, in thefirst case, the ghost image would be comprised of reflected tissue fromabove the scanning area while in the second case, the ghost image wouldbe comprised of reflected tissue from below the scanning area. Likewise,by ANDing the two scans together, the ghost image can be attenuatedwhile the recurrent tissue features in the two images will bereinforced. Although in this case the two images may comprise scanshaving zero delay points on opposite sides (for example, top and bottom)of the B-scan image, in various embodiments, the scans of the sametissue can be otherwise perturbed so as to change the ghost images,while substantially maintaining the imaged tissue features. As describedabove, applying a logical AND process on these scans can cause thedifferent ghosting images to be attenuated, minimized or removed incontrast to the recurrent tissue features in the two scans, which willbe reinforced or otherwise remain. In some embodiments, these processesmay be performed in an interactive fashion to progressively remove ghostimage artifacts.

Additionally, in various embodiments, the ghost image could beattenuated, minimized or removed by arithmetically subtracting amirrored image similar to the ghost image. If, for example, the ghostimage is an image of the cornea, an image of the cornea can be obtainedfrom a separate scan and used to subtract out the ghost image. Incertain embodiments, for example, data of neighboring scans can be used.For example, B-scan images that are more anterior can be mirrored aroundtheir lower border and can be subtracted from subsequent images that areposterior. Alternatively, B-scan images that are more posterior can bemirrored about their upper border and subtracted from images that areanterior. Additionally, prior B-scan images can be subtracted fromprevious B-scan images or vice-versa. Although there may be differencesbetween the ghost image and the mirrored image, for example, there maybe differences in intensity and shifting of the eyes due to movement ofthe eyes, mirroring and subtracting may substantially reduce the ghostimage while not consistently affecting the real tissue image.

Also, in certain embodiments, the ghost image can be addressed by usingoverlapping scans. A large overlap segment may comprise, for example,25% or 50% of the B-scan depth. In example of this embodiment, thez-offset position of subsequent B-scans can be shifted posteriorly by anamount less than the current B-scan depth. For example, for a B-scanthat has a depth of 2 mm, a subsequent B-scan that could also have adepth of 2 mm would overlap by 50% if the z-offset position was changedonly by 1 mm. The overlap may be, for example, at least 20%, 30%, 40%,50%, although other values are possible. In various embodiments theamount of overlap is known. Logical AND operations can be performed onsequential scans shifted by this known offset amount. As describedabove, the logical AND process can reinforce data that is common betweenthe two scans (real image) versus mirror ghost images, which will bedifferent in the two scans. A logical AND process may, for example, beused. However, a wide variety of variations are possible.

In certain embodiments, light sources, optical configurations, and/orprocessing capable of providing deep penetration, can be used to enabledeeper scans and thus, coverage of the eye in fewer scan sequences. Incertain embodiments, the sequential axial scans can be programmaticallycontrolled so that changes in the focus of the device are coordinatedwith changes in the z-offset position between sets of B-scans orientedalong the longitudinal axis of the eye. For example, the OCT-basedophthalmic testing center system can be configured to begin to captureOCT scans of the anterior segment at the approximate distance expected(based, e.g., on the location of the ocular cups) when the ocular cupsof the OCT-based ophthalmic testing center system are placed against theuser's eye sockets and then z-offsets and autofocus can be performed foreach successive scan as discussed previously. One example of anautomated process for generating an OBM image based on multiplesequential scans of variable depth can be performed by the OCT-basedophthalmic testing center system as follows. In one embodiment, a firstaxial 3D or radial-line B scan can be performed with a particular presetdepth, such as 3 mm. Based on the preset thickness of this first B-scanset, the OCT-based ophthalmic testing center system can be configured tomove the z-offset posteriorly by a certain distance in preparation forthe next sequential axial scan. If the focal depth of the variable focuslens system is not adequate to focus on the new posterior position, theOCT-based ophthalmic testing center can be configured to move the focalpoint of the variable focus lens system posteriorly by substantially thesame amount as the z-offset. In certain embodiments, the z-offsetdistance can be configured such that the depth of the next sequentialscan is less than the depth of the previous scan in order to induceoverlap of scan data. In various embodiments, the z-offset distance canbe configured such that the depth of the next sequential scan is equalto the depth of the previous scan. In still other embodiments, thez-offset distance can be configured such that the depth of the nextsequential scan exceeds the depth of the first scan. The automated OBMimaging process can be continuously repeated until the retina andchoroid are encountered, at which point a completeretina/choroidal/optic nerve scan can be completed, thereby concludingthe imaging portion of the OBM test.

In certain embodiments, the aggregate scan (whether A-scan, B-scan, 3-DOCT scan) that is compiled does not extend from the cornea to the retinabut may extend a different distance which may be a least 3 mm, 5 mm, 7mm, 9 mm, 11 mm, 13 mm, 15 mm, 17 mm, 19 mm, 21 mm, 23 mm, 25 mm, 27 mm,29 mm, 31 mm, 33 mm, 35 mm, 37 mm, 39 mm. In various embodiments, theOBM image of the entire depth of the eye can be comprised of multipleindividually-acquired A-scans. In certain embodiments, the OBM image canbe comprised of thousands of A-scans. In certain embodiments, eachindividual A-scan can be depth-scanned such that focus and z-offset arevaried throughout acquisition of the individual A-scan. Raster or radialline compilations of these A-scans can enable 3D viewing of OBM images.FIG. 38 illustrates a simulated OBM image 3810 generated by multipleindividually-acquired A scans and a virtual representation of an OBMimage 3812 illustrating the compilation of individually-acquiredA-scans. In various alternative embodiments, the depth of the A-scanscan be configured to extend as far as the light source allows, to extendto some preset depth, or to continue until the retina or choroid isencountered. In certain embodiments, an average location for the retinaand choroid can be used so that A-scans with ambiguous endpoints canbenefit from data from adjacent A-scans. In various embodiments, asuitable light source, optics, and processing may be employed to capturethe entire axial length of the eye in one A-scan, a depth that canexceed 35 mm, without substantially changing focus or z-offset. Incertain embodiments, the A-scans generated can be combined in a rasteror radial line pattern to form a 3D-OCT of the whole eye or at least asubstantial portion of the whole eye. In some embodiments, A-scansgenerated can be used to plan the final depth and breakdown ofsequential scans required to complete the sequential 3D-OCT capturepattern described above. The OBM image data can be used by physicians inmany ways. In one embodiment, physicians can view the 3D scans of theeye as individual B-scans or in 3D mode. In another embodiment, thephysicians can perform qualitative assessments of the features in thescans or view historical, or serial, sets of scans side-by-side toevaluate disease progression. In another embodiment, software modules orroutines can be used to delineate various boundaries, such as thecorneal boundaries, the pupillary boundaries, or the retinal boundaries,and provide measurements of these features based on the detectedboundaries. In various alternative embodiments, the software modules orroutines can be performed on the processing unit of the ophthalmictesting center system itself, on a processor of an attached computer, oron a remote computer that is connected to the ophthalmic testing centersystem via wired or wireless networking. The provided measurements canbe compared with measurements from previous examinations, if available.In another embodiment, the OCT-based ophthalmic testing center systemcan be configured to use automated classifications algorithms todetermine the identity of each pixel within the 3D dataset, such asidentifying subretinal tissue, vitreous cells, or abnormal iris vessels,and extract quantitative measurements of these classified structures.Other measurements and analyses are possible without departing from thespirit and/or scope of the disclosure.

If processed in real-time, the OCT biomicroscopy data can be used toaugment additional scans in the same session. For example, in certainembodiments, if the system is configured to perform radial line scans inthe vitreous cavity but encounters many small bright signals duringanalysis, which can be indicative of bleeding or infection, theOCT-based ophthalmic testing center system can be configured to performmore dense scanning in this region to further elucidate theabnormalities. In various embodiments, the OCT-based ophthalmic testingcenter system can be configured to compare the OBM measurements to anormative database to determine patterns of deviation and/or generaterisk assessments and/or clinical reports. In various embodiments, theOCT-based ophthalmic testing center system can be configured to analyze,compare, and/or add the OBM data to other data, such as the subject'sophthalmic history data that is stored on a subject's input card orretrieved from a historical database or other history-taking modulesincorporated into the OCT-based ophthalmic testing center system. Forexample, the OCT-based ophthalmic testing center system can beconfigured to automatically perform periodic OBM scans on patients withchronic and/or potentially progressive conditions, such as corneal edemaor keratoconus, or on patients with contact lenses to evaluate contactlens fit. In various embodiments, the OCT-based ophthalmic testingcenter system can be configured to automatically conduct and store anOBM image whenever another ophthalmic test is ordered and/or performed.The OCT-based ophthalmic testing center system can be configured togenerate various statistics based on the OBM data, which may be combinedwith data from the normative database or historical data source.

With reference to FIG. 38, the OCT-based ophthalmic testing centersystem can be configured to output the results of and/or data from theOBM imaging and analysis. For example, the results can be outputteddirectly to the subject in a hardcopy (for example, printed card orpaper) or electronic format (for example, on a display, via email, textmessaged, or in a magnetic strip), stored locally on the device or on anattached computer, transmitted to a central database, or transmitteddirectly to the ordering or related physician.

In one embodiment, the OCT-based ophthalmic testing center systemcontains two independent OCT systems capable of capturing simultaneousOCT scans for each eye. In this embodiment, scanning protocols andmeasurements can be determined independently for each side. In anotherembodiment, the ophthalmic testing center system can be configured tostop moving from anterior to posterior when arriving at a structure ofinterest. For example, the ophthalmic testing center system can bedirected to stop at the iris/pupillary plane as it moves fromfront-to-back. At this point, it may be configured to capture high speedbilateral B-scans (e.g., in 20 ms, 10 ms, 5 ms, 2 ms, 1 ms or less) toperform bilateral ophthalmic measurements, such as pupillometry (asdiscussed in further detail below). In another embodiment, theophthalmic testing center system can stop scanning when it reaches theretina in order to perform measurements based on the location of bothfoveae (as discussed above in connection with strabismus and amblyopia).

Extraocular Motility Testing

With reference to FIG. 39, extraocular motility, or extraocularmovement, is generally a measurement of the extent of movement of theeyes in various directions of gaze and can be used to detect a motilitydeficit. Extraocular motility testing can be performed on children andadults.

In reference to FIG. 39, an OCT-based ophthalmic testing center systemcould accomplish extraocular motility testing in either a self-operatedor self-administered fashion, or in an assisted fashion where someoneother than the subject either partially or completely administers thetest. The extraocular motility test is a functional test that can employeye tracking methodologies, for example, tracking the fovea using fovealverification and/or foveal location. The extraocular motility test canbe performed on both eyes simultaneously (versions) or first on one eyeand then on the other eye (ductions). In various embodiments, theOCT-based ophthalmic testing center system can be configured to displaystationary fixation targets, such as dots, crosses, circles, or imagesin the ocular displays. The OCT-based ophthalmic testing center systemcan be configured to control the optical distance between the subject'seye and the fixation targets by adjusting the vergence of the light fromthe fixation display (for example, by collimation or divergence). Forexample, the optical distance could be set at 14 inches to simulatereading, 30 inches to simulate computer use, 20 feet to equate withconventional visual acuity measurements, infinity, or at any otherdistance.

In various embodiments of the testing phase, the fixation targets can beconfigured to move in one or both oculars to one of many predeterminedpositions, such as the nine cardinal positions of gaze. In certainembodiments, the fixation targets can be configured to momentarily dwellat each of the predetermined positions to enable measurement of motilityalong various axes of the eye. In certain embodiments, the OCT-basedophthalmic testing center system can be configured to instruct (visuallyand/or audibly) the subject to follow the fixation targets throughoutthe examination. The instruction can be auditory and/or visual invarious embodiments.

The OCT-based ophthalmic testing center system can be configured tomonitor the subject's gaze using OCT and/or non-OCT imaging modalitiesto ensure that the subject's gaze, either demonstrated by a fovealdepression under the image of the fixation target on the retina or byappropriately changing locations for other retinal features, remainsfixed on the moving or dwelling target. OCT imaging modalities caninclude, for example, foveal verification using small 3D-OCT scanscentered on the image of the fixation target on the retina and/or foveallocation using sparse 3D-OCT scans across the fundus. Non-OCT imagingmodalities can include, for example, infrared (“IR”) or scanning laserophthalmoscopy (“SLO”) imaging.

In certain embodiments, the OCT-based ophthalmic testing center systemcan be configured to first perform foveal verification. Detection of thefoveal depression or “best fixating retina” at the expected location fora particular dwell point can indicate intact motility in thecorresponding axis, whereas absence of a foveal depression can indicatea motility deficit. In certain embodiments, the OCT-based ophthalmictesting center system can be configured to continue on with the testwithout performing a foveal location if the presence of the fovea isdetected for a particular dwell point. In the absence of a foveal oroptic nerve depression within the expected region, the OCT-basedophthalmic testing center system can be configured to perform foveallocation to quantify the motility deficit. As described above inconnection with foveal verification and foveal location, the analysis todetect these features can comprise edge detection of the vitreoretinal(“VR”) interface to detect the foveal depression, edge detection of thevitreoretinal interface and RPE to determine retinal thickness, edgedetection of other retinal features, topographic or thickness slopecalculations followed by 2D registration to previous maps, among otheranalyses.

In certain embodiments, if the subject's gaze departs from the fixationtarget, the OCT-based ophthalmic testing center system can be configuredto remind the subject (for example, visually or audibly) to follow thefixation target. In various embodiments, the OCT-based ophthalmictesting center system can be configured to reject the currentmeasurement and start the test or current measurement over.

In certain embodiments, measurements made with the extraocular motilitytest can include, but are not limited to, ratios of the actual distancetraveled by the fovea in each axis over the expected distance to thedwell point in each axis, such as 75% or 110%; the actual angletraveled, such as 45 degrees; and/or the angular ratio (actual angletraveled over the expected angle traveled) for each axis, such as 75%.FIG. 39 graphically illustrates an example of extraocular motility testresults for a subject with a motility deficit on the right side. Theactual foveal locations (illustrated as circles) are aligned with theexpected foveal locations (illustrated as crosses) for the left andcentral dwell points, indicating 100% motility. For the three dwellpoints on the right with deficient motility (less than 100%), the actualfoveal locations do not align with the expected foveal locations. Thedashed lines represent the various axes traveled by the fixation targetduring the testing phase. The percentages listed at the eight dwellpoints represent the ratios of the actual distance traveled by the foveain each axis over the expected distance to the dwell point in each axis.

In certain embodiments, the extraocular motility data is presentedseparately for versions and ductions. In various embodiments, theOCT-based ophthalmic testing center system can be configured to employlogic to combine the extraocular motility measurements to deducepotential underlying cranial nerve palsies, such as third, fourth andsixth cranial nerve palsies. In certain embodiments, the OCT-basedophthalmic testing center system can be configured to combine theextraocular motility testing with the performance of strabismusevaluations (which are described in detail above). For example, theOCT-based ophthalmic testing center system can advantageously beconfigured to perform strabismus evaluations by analyzing thedifferences in foveal locations of the fellow eyes while the subject isgazing in different directions. This combination of extraocular motilitytesting with strabismus testing can advantageously aid in generatingmore information about the type of strabismus. Other measurements andanalyses are possible without departing from the spirit and/or scope ofthe disclosure. If processed in real-time, the OCT-based ophthalmictesting center system can be configured to use the extraocular motilitytest data in conjunction with or to augment additional testing for thesubject. In various embodiments, the OCT-based ophthalmic testing centersystem can be configured to compare the extraocular motility test datato a normative database to determine patterns of deviation and/orgenerate risk assessments and/or clinical reports. In variousembodiments, the OCT-based ophthalmic testing center system can beconfigured to analyze, compare, and/or add the extraocular motility testdata to other data, such as the subject's ophthalmic history data thatis stored on a subject's input card or retrieved from a historicaldatabase or other history-taking modules incorporated into the OCT-basedophthalmic testing center system. The OCT-based ophthalmic testingcenter system can be configured to generate various statistics, based onthe measured extraocular motility data, which may be combined with datafrom the normative database or historical data source.

With reference to FIG. 39, the OCT-based ophthalmic testing centersystem can be configured to output the results of and/or data from theextraocular motility test. For example, the results can be outputteddirectly to the subject in a hardcopy (for example, printed card orpaper) or electronic format (for example, on a display, via email, textmessaged, or in a magnetic strip), stored locally on the device or on anattached computer, transmitted to a central database, or transmitteddirectly to the ordering or related physician.

Pupillometry

With reference to FIG. 40, pupillometry is generally a measurement ofpupillary reactions, or pupillary responses. Pupillary reactionabnormalities can often signify serious disease, such as central nervoussystem disease. Pupillometry measurements can also be used to detectsubtle optic nerve dysfunction in diseases such as early glaucoma.Pupillometry can be performed on children and adults. In general, thereare two major types of pupillary responses (direct and consensual). Thedirect response occurs when a pupil constricts to a visual stimulus,such as a bright light, presented directly to that eye. The consensualresponse occurs when a pupil constricts in response to a visual stimuluspresented to the fellow eye.

In reference to FIG. 40, an OCT-based ophthalmic testing center systemcould accomplish pupillometry in either a self-operated orself-administered fashion, or in an assisted fashion where someone otherthan the subject either partially or completely administers the test. Ingeneral, pupillometry is a structural test. In certain embodiments, thepupillometry test does not employ eye tracking methodologies; however,In various embodiments, eye tracking methodologies can be used, forexample, tracking the fovea using foveal verification and/or foveallocation. The pupillometry test is a binocular test and can be performedon both eyes simultaneously; however, in certain embodiments, thepupillometry test can be performed on one eye only or first on eye andthen on the other. In various embodiments, the OCT-based ophthalmictesting center system can optionally display stationary fixationtargets, such as dots, crosses or circles at the start of thepupillometry test. In embodiments where pupillary reactions toaccommodation are to be tested, the OCT-based ophthalmic testing centersystem can be configured to control the optical distance between thesubject's eye and the fixation targets by adjusting the vergence of thelight from the fixation display (for example, by collimation ordivergence) prior to acquiring B-scans through the iris planes. Forexample, the optical distance could be set at 14 inches to simulatereading, 30 inches to simulate computer use, 20 feet to equate withconventional visual acuity measurements, infinity, or at any otherdistance. In one embodiment of the testing phase, bright stimuli couldbe flashed at one or both eyes by filling the entire display screen onone or each side of the binocular visual interface with a bright color,such as white, or using an independent light source to provide a flashstimulus. In various embodiments, the OCT-based ophthalmic testingcenter system can be configured to instruct (visually and/or audibly)the subject to look straight ahead at fixation targets (if present).During various embodiments of the testing phase, the OCT-basedophthalmic testing center system device can be configured to capturebilateral simultaneous OCT B-scans through the iris/pupillary plane inboth eyes at high speeds (for example, at least 10 per second, 50 persecond or 100 per second) to detect pupillary responses to accommodationor visual stimuli, as described in more detail in the OCT biomicroscopysection above. In various embodiments, the OCT-based ophthalmic testingcenter system can be configured to analyze the resulting OCT images withimage processing algorithms, such as edge detection routines, togenerate measurements of various parameters of pupillary responses, suchas size, latency, velocity, acceleration, and amplitude.

With reference to FIG. 40, OCT image 4002 illustrates normal mid-dilatedpupils in dim light. OCT image 4004 illustrates a direct and consensualpupillary response in normal eyes. In general, the pupillary response innormal eyes should be substantially symmetric in all parameters (asillustrated by OCT image 4004). In eyes with diseases of the optic nerveor pupillary pathways, including glaucoma, the highly quantitativemeasurements of the OCT-based ophthalmic testing center system can beconfigured to detect asymmetries that may arise. For example, in certainembodiments, a relative afferent pupillary defect in a left eye can bedetected if the flash stimulus in the right eye leads to both direct(right eye) and consensual (left eye) pupillary constriction, while aflash stimulus in the left eye leads to less constriction on both sides(as illustrated by OCT image 4006). Other measurements and analyses arepossible without departing from the spirit and/or scope of thedisclosure.

If processed in real-time, the OCT-based ophthalmic testing centersystem can be configured to use the pupillometry test data inconjunction with or to augment additional test stimuli presented to thesubject. For example, if a test result is equivocal or close to theborderline of normal, a dimmer stimulus or a flicker stimulus can bepresented to the user. In another example, if a pupillary defect isfound to be present, the OCT-based ophthalmic testing center system canbe configured to automatically perform perimetry or extraocular motilitytesting. In various embodiments, the OCT-based ophthalmic testing centersystem can be configured to compare the pupillometry test data to anormative database to determine patterns of deviation and/or to generaterisk assessments and/or clinical reports. In various embodiments, theOCT-based ophthalmic testing center system can be configured to analyze,compare, and/or add the pupillometry test data, to other data, such asthe subject's ophthalmic history data that is stored on the subject'sinput card or retrieved from a historical database or otherhistory-taking modules incorporated into the OCT-based ophthalmictesting center system. In certain embodiments, the OCT-based ophthalmictesting center system can be configured to automatically perform apupillometry test upon detection of increased optic disc cupping or athinned retinal nerve fiber layer. The OCT-based ophthalmic testingcenter system can also be configured to generate various statistics,based on the pupillometry data, which may be combined with data from thenormative database or historical data source.

With reference to FIG. 40, the OCT-based ophthalmic testing centersystem can be configured to output the results of and/or data from thepupillometry test. For example, the results can be outputted directly tothe subject in a hardcopy (for example, printed card or paper) orelectronic format (for example, on a display, via email, text messaged,or in a magnetic strip), stored locally on the device or on an attachedcomputer, transmitted to a central database, or transmitted directly tothe ordering or related physician.

In certain embodiments, the OCT-based ophthalmic testing center systemcan be configured to detect the pupil centers on each side to refine theinterpupillary distance of the oculars to ensure that they remaincentered on each eye's optical axis. In various embodiments, furtherrefinement of the interpupillary distance can be guided by the imagequality of the B-scans on each side. For example, if B-scans on eitherside were of low quality, the OCT-based ophthalmic testing center systemcan be configured to increase or decrease the interpupillary distance.If adjustment in one direction improves the average image quality of thetwo sides, the OCT-based ophthalmic testing center system can beconfigured to continue to pursue changes in that direction until theaverage image quality is optimized. In certain embodiments,interpupillary distance adjustment can be performed in the horizontaland vertical axes, instead of only the horizontal axis.

Exophthalmometry

With reference to FIG. 41, exophthalmometry is generally a measurementof the extent of protrusion or bulging of the eyeballs from, orrecession or sinking of the eyeballs into, the eye sockets. Protrusionof the eyes from the eye sockets can signify orbital diseases, such asthyroid eye disease. Recession of the eyes within the eye sockets maysimply occur with age but may also be a condition that arises aftertrauma to the eyes and eye sockets. Exophthalmometry measurements aregenerally recorded in millimeters. Exophthalmometry testing can beperformed on children and adults.

In reference to FIG. 41, the OCT-based ophthalmic testing center systemcan be configured to conduct exophthalmometry testing, which isgenerally a structural test that can employ OCT biomicroscopy. Incertain embodiments, the OCT-based ophthalmic testing center system canbe configured to conduct exophthalmometry testing in either aself-operated or self-administered fashion, or in an assisted fashion,in which someone other than the subject either partially or completelyadministers the test. The exophthalmometry test can be performed usingeither a binocular system or a monocular system. For example, theexophthalmometry test could be performed in both eyes simultaneously orfirst on one eye and then on the other eye. In certain embodiments, theOCT-based ophthalmic testing center system can comprise display devicesconfigured to display stationary fixation targets, such as dots,crosses, circles, or other images during the test. The OCT-basedophthalmic testing center system can be configured to instruct (visuallyand/or audibly) the subject to look straight at the fixation targetsthroughout the examination. If larger than usual axial variations incorneal location are detected, the OCT-based ophthalmic testing centersystem can be configured to instruct (visually and/or audibly) thesubject to stabilize the ocular cups on their orbital rims and repeatthe test.

In certain embodiments, the OCT-based ophthalmic testing center systemcan be configured to capture high-speed bilateral B-scans that passthrough the anterior segments of each eye, as described in more detailin the OCT biomicroscopy section above. The OCT-based ophthalmic testingcenter system can be configured to identify the anterior-most cornealinterface, or apex of the cornea, 4102 by performing edge detectionalgorithms on the B-scans of the right and left eyes. For example, ifradially-oriented B-scans are acquired, many of the scans may passthrough the optical axis of the eye, which may coincide with the apex ofthe cornea. Alternatively, a 3D-OCT scan set can be obtained and theOCT-based ophthalmic testing center system can be configured todetermine the apex of the cornea by comparing the anterior-mostmeasurement from one or more scans in the 3D-OCT set.

Exophthalmometry measurements can be expressed as individual absolutemeasurements (in reference to the distal eye cup resting on the orbit)or as relative measurements (in reference to the other eye or inreference to a past examination). In general, absolute measurementsreflect the distance to the front of the corneas from the orbital rimand relative measurements reflect the distance between the corneal apexof one eye and the corneal apex of the other eye. With reference to FIG.41, in certain embodiments, an absolute exophthalmometry measurement canbe obtained by subtracting the distance between the start of theanterior-most B-scan and the apex of the cornea (labeled as 4104) fromthe z-offset value at the start of the B-scan set (labeled as 4106).Although various locations and distances have been illustrated on theleft or right eye to reduce clutter, it should be appreciated thatcorresponding locations and distances (albeit not necessarily identical)exist with respect to the fellow eye. In various embodiments, anabsolute exophthalmometry measurement can be obtained using the refinedcorneal boundary 4108 from segmentation of the 3D-OCT scan set, asdescribed previously. Because the distance between the OCT instrumentand the end of the eyecups (resting on the orbital rims) is also known,this distance can be subtracted from the absolute exophthalmometrymeasurements to calculate the distance between the front of the corneasand the orbital rims. FIG. 41 illustrates a potential anterior-posteriorlocation of the orbital rim 4110 of the left eye. The relativeexophthalmometry measurement can be calculated by subtracting theabsolute exophthalmometry measurement for one eye from the absolutemeasurement for the fellow eye. For example, if one eye is 22 mm and theother eye is 19 mm, the relative exophthalmometry measurement is 3 mm.

In certain embodiments, the OCT-based ophthalmic detection center can beconfigured to record the interpupillary distance used to perform theexophthalmometry measurements. The interpupillary distance can then beused as a base measurement to provide consistency between successivetests. Other measurements and analyses can also be performed by theOCT-based ophthalmic detection center during exophthalmometry testingwithout departing from the spirit and/or scope of the invention. Forexample, exophthalmometry testing can be conducted while the subject isgazing in a direction other than straight ahead in order to measureexophthalmos due to extraocular muscle disorders.

In certain embodiments, the OCT-based ophthalmic testing center systemcan be configured to compare the exophthalmometry test data to anormative database to determine patterns of deviation and/or generaterisk assessments and/or clinical reports. In various embodiments, theOCT-based ophthalmic testing center system can be configured to analyze,compare, and/or add the exophthalmometry test data to other data, suchas the subject's ophthalmic history data that is stored on a subject'sinput card or retrieved from a historical database or otherhistory-taking modules incorporated into the OCT-based ophthalmictesting center system. In certain embodiments, the OCT-based ophthalmictesting center system can be configured to automatically conduct anexophthalmometry test based on ophthalmic history. In variousembodiments, if the patient has a family history of thyroid disease, orthe patient complains of symptoms associated with thyroid disease, andsuch information is stored within the patient's ophthalmic historydatabase, the OCT-based ophthalmic testing center system can beconfigured to automatically perform an exophthalmometry test. TheOCT-based ophthalmic testing center system can be configured to generatevarious statistics based on the measured exophthalmometry test data,which may be combined with data from the normative database orhistorical data source.

With reference to FIG. 41, the OCT-based ophthalmic testing centersystem can be configured to output the results of and/or data from theexophthalmometry test. For example, the results can be outputteddirectly to the subject in a hardcopy (for example, printed card orpaper) or electronic format (for example, on a display, via email, textmessaged, or in a magnetic strip), stored locally on the device or on anattached computer, transmitted to a central database, or transmitteddirectly to the ordering or related physician.

Visual Acuity Testing

With reference to FIG. 42, in general, visual acuity testing measures asubject's acuteness or clarity of vision. In various embodiments, theOCT-based ophthalmic testing center system can be configured to conductvisual acuity testing, which is generally a functional test that canemploy eye tracking methodologies, for example, tracking the foveaeusing foveal verification and/or foveal location. The eye trackingmethodologies can also be used to determine the frequency, speed, andamplitude of foveal movements. In various embodiments, the eye trackingmethodologies can be performed in real-time to modify test strategy.

In reference to FIG. 42, the OCT-based ophthalmic testing center systemcan be configured to conduct visual acuity testing in either aself-operated or self-administered fashion, or in an assisted fashion,in which someone other than the subject either partially or completelyadministers the test. The visual acuity testing can be performed on botheyes simultaneously or, first on one eye and then on the other eye. TheOCT-based ophthalmic testing center system can be configured to controlthe optical distance between the subject's eye and the fixation targetsby adjusting the vergence of the light from the fixation display (forexample, by collimation or divergence). For example, the opticaldistance could be set at 14 inches to simulate reading, 30 inches tosimulate computer use, 20 feet to equate with conventional visual acuitymeasurements, infinity, or at any other distance. As discussedpreviously, the OCT-based ophthalmic testing center system can beconfigured to correct for refractive error at the various opticaldistances.

The OCT-based ophthalmic testing center system can comprise displaydevices that can be configured to display alphanumeric symbols. Withreference to FIG. 42, in various embodiments, the display devices of theOCT-based ophthalmic testing center system can be configured to displaySnellen or ETDRS letters 4202 of varying size, contrast, spacing, fontand color (with or without crowding bars for subjects with amblyopia).In another embodiment, the varying alphanumeric symbols can be displayedsimultaneously (as illustrated in FIG. 42) or in serial fashion. Invarious embodiments the OCT-based ophthalmic testing center system canbe configured to instruct (visually and/or audibly) the subject to readthe alphanumeric symbols out loud (for example, via a speaker orheadphone jack). The OCT-based ophthalmic testing center system can beconfigured to capture these verbalizations or voice responses using theOCT-based ophthalmic testing center system's microphone input device andprocess the verbalizations or voice responses using the OCT-basedophthalmic testing center system's processing unit and speechrecognition software to determine letter recognition accuracy. If thesubject's response is determined to be correct, the OCT-based ophthalmictesting center system can be configured to display another letter untilthe number of letters for that acuity level is satisfied. The OCT-basedophthalmic testing center system can be configured to then move on tosmaller sets of letters until the user error reaches a predeterminedthreshold, such as 50% of the letters in a line. In various embodiments,the OCT-based ophthalmic testing center system can be configured tomodify the test strategy in real-time based on a subject's performancein order to improve the quality and/or accuracy of the test. Forexample, the OCT-based ophthalmic testing center system can beconfigured to ask the user to repeat or retry incorrect letters. Invarious embodiments, the measurement of the subject's visual acuity thatwould be recorded and/or output by the OCT-based ophthalmic testingcenter system is the visual acuity corresponding to the last set ofletters read that did not fail termination criteria.

In another embodiment, the OCT-based ophthalmic testing center systemcan be configured to display optokinetic targets, such as alternatinglight and dark lines 4204, 4206 that move laterally at a predeterminedspeed. This type of visual acuity testing advantageously provides afaster and more objective measure of visual acuity and does not requireliteracy or verbal feedback. The OCT-based ophthalmic testing centersystem can be configured to vary the size/frequency of the targets, thespeed at which the targets move and the color/contrast of the targets toprovide more detailed information about the acuity. The movingoptokinetic targets can provide a stimulus that is configured to elicitresponsive eye movements in subjects able to see that frequency ofinformation.

In certain embodiments, OCT or non-OCT eye tracking modalities can beused to track fundus features, such as the fovea, to determine if thesubject's eye is moving at the appropriate frequency and amplitude inresponse to the optokinetic stimulus. For example, the OCT-basedophthalmic testing center system can be configured to capture rapidsmall 3D-OCT scans, sparse 3D-OCT scans, or use non-OCT imaging, such asIR or SLO, to track the fovea or other fundus features, as describedpreviously. In the absence of a foveal or optic nerve depression (forexample, for subjects suffering from retinal disease), the relativeslopes of the retinal surface can be used to indicate eye movement awayfrom either the past fundus position or the position at the start of thetest using mathematical registration algorithms. In certain embodiments,the OCT-based ophthalmic testing center system can be configured todetermine the subject's visual acuity by calculating the minimum linewidth, maximum speed and/or the minimum color/contrast that elicitsoptokinetic responses.

With reference to FIG. 42, in certain embodiments, the OCT-basedophthalmic testing center system can be configured to use suppressionstimuli 4208 (for example, small stationary features in the middle ofthe optokinetic field), to estimate visual acuity. For example, anOCT-based ophthalmic testing center system can be configured to increasethe size of the suppression stimuli 4208 until the optokinetic responseis suppressed. In certain embodiments, this threshold can be used byOCT-based ophthalmic testing center system to approximate visual acuity.Other measurements and analyses are possible without departing from thespirit and/or scope of the disclosure. For example, modification of thespeed of movement for a given spatial frequency of optokinetic stimulicould be used to estimate reading speed. If processed in real-time, theOCT-based ophthalmic testing center system can be configured to usethese data to augment additional test stimuli presented to the subject.For example, the OCT-based ophthalmic testing center system can beconfigured to first present optokinetic stimuli of progressivelydecreasing spatial frequency. If a subject's foveal response matches theoptokinetic stimuli even at the smallest spatial frequency, the devicecan be configured to begin to present suppression stimuli atprogressively larger sizes until the optokinetic response ceases.

As discussed in more detail above, at the conclusion of the visualacuity test for each eye, a set of reference 3D-OCT scans of each eyecan advantageously be acquired that indicate the fundus position that ispreferred for optimal visual acuity in each eye, or the “best fixatingretina”. The images of the preferred fundus position, or best fixatingretina, can be stored and used as references for tests that requireverification of foveal position or foveal localization, as describedelsewhere. The reference images can be helpful in subjects with diseasesthat distort the normal anatomy of their foveal depression.

With reference to FIG. 42, the OCT-based ophthalmic testing centersystem can be configured to compare the visual acuity test data to anormative database to determine patterns of deviation and/or to generaterisk assessments and/or clinical reports. In certain embodiments, theOCT-based ophthalmic testing center system can be configured to analyze,compare, and/or add the visual acuity test data to other data, such asthe subject's ophthalmic history data that is stored on a subject'sinput card or retrieved from a historical database or otherhistory-taking modules incorporated into the OCT-based ophthalmictesting center system. In certain embodiments, the OCT-based ophthalmictesting center system can be configured to automatically conduct avisual acuity test based on ophthalmic history and/or at the start ofevery round of ophthalmic testing to provide a set of reference imagesfor use in eye tracking or fixation monitoring for subsequent ophthalmictests, as discussed above. In another example, if the subject has afamily history of poor visual acuity or the like, and such informationis stored within the subject's ophthalmic history database, theOCT-based ophthalmic testing center system can be configured toautomatically perform a visual acuity test. The OCT-based ophthalmictesting center system can be configured to generate various statisticsbased on the measured visual acuity test data, which may be combinedwith data from the normative database or historical data source.

With reference to FIG. 42, the OCT-based ophthalmic testing centersystem can be configured to output the results of and/or data from thevisual acuity test. For example, the results can be outputted directlyto the subject in a hardcopy (for example, printed card or paper) orelectronic format (for example, on a display, via email, text messaged,or in a magnetic strip), stored locally on the device or on an attachedcomputer, transmitted to a central database, or transmitted directly tothe ordering or related physician.

Photostress Recovery Time Test

In general, photostress recovery time is a test that is hypothesized todifferentiate retinal disease from optic nerve disease. In variousembodiments, the OCT-based ophthalmic testing center system can beconfigured to conduct photostress recovery time testing, which isgenerally a functional test that can employ eye tracking methodologies,for example, tracking the foveae using foveal verification and/or foveallocation. The eye tracking methodologies can also be used to determinethe frequency, speed, and amplitude of foveal movements.

In various embodiments, the OCT-based ophthalmic testing center systemcan be configured to conduct photostress recovery time testing in eithera self-operated or self-administered fashion, or in an assisted fashion,in which someone other than the subject either partially or completelyadministers the test. The photostress response time testing can beperformed on both eyes simultaneously or, first on one eye and then onthe other eye. The OCT-based ophthalmic testing center system can beconfigured to control the optical distance between the subject's eye andthe fixation targets by adjusting the vergence of the light from thefixation display (for example, by collimation or divergence). Forexample, the optical distance could be set at 14 inches to simulatereading, 30 inches to simulate computer use, 20 feet to equate withconventional visual acuity measurements, infinity, or at any otherdistance. As discussed previously, the OCT-based ophthalmic testingcenter system can be configured to correct for refractive error at thevarious optical distances. In various embodiments, the OCT-basedophthalmic testing center system can be configured to measure visualacuity by presenting letters from a Snellen or ETDRS chart and measuringthe letter accuracy based on the subject's verbal responses, asdescribed in more detail above. The OCT-based ophthalmic testing centersystem can then be configured to flash one or both eyes with a brightstimulus, such as a bright white display for a predetermined exposuretime (for example, at least 0.5 seconds, 1 second, 5 seconds, tenseconds, or 30 seconds), and then measure the time it takes for thesubject to read one line of visual acuity above their previous bestrecorded visual acuity.

In another embodiment, the OCT-based ophthalmic testing center systemcan be configured to measure visual acuity using optokinetic stimuli, asdescribed in more detail above. The OCT-based ophthalmic testing centersystem can then be configured to flash one or both eyes with a brightstimulus, such as a bright white display for a predetermined exposuretime (for example, ten seconds), and then measure the time that it takesfor the subject to respond to optokinetic stimuli slightly larger thanthe subject's threshold response from the visual acuity test. In yetanother embodiment, the OCT-based ophthalmic testing center system canbe configured to conduct photostress recovery time testing independentlyof visual acuity testing using visual acuity results stored from aprevious visual acuity test. Other measurements and analyses arepossible without departing from the spirit and/or scope of thedisclosure. If processed in real-time, the OCT-based ophthalmic testingcenter system can be configured to use these measurements to augmentadditional test stimuli presented to the subject. For example, if, aftera certain period of time, the subject is still unable to read one levelabove their best visual acuity, the OCT-based ophthalmic testing centersystem can be configured to begin to increase the size of the stimulusto determine at what point the subject will respond to the stimulus. Incertain embodiments, the OCT-based ophthalmic testing center system canalso be configured to repeat the test again with this larger stimulus ordecrease the exposure time of the bright stimulus to the subject's eye.

In various embodiments, the OCT-based ophthalmic testing center systemcan be configured to compare the photostress response time test data toa normative database to determine patterns of deviation and/or togenerate risk assessments and/or clinical reports. In certainembodiments, the OCT-based ophthalmic testing center system can beconfigured to analyze, compare, and/or add the photostress response timetest data to other data, such as the subject's ophthalmic history datathat is stored on a subject's input card or retrieved from a historicaldatabase or other history-taking modules incorporated into the OCT-basedophthalmic testing center system. In certain embodiments, the OCT-basedophthalmic testing center system can be configured to automaticallyconduct a photostress response time test based on ophthalmic history. Inanother example, if the subject has a family history of macular diseaseor the like, and such information is stored within the subject'sophthalmic history database, the OCT-based ophthalmic testing centersystem can be configured to automatically perform a photostress responsetime test. The OCT-based ophthalmic testing center system can beconfigured to generate various statistics based on the measuredphotostress response time test data, which may be combined with datafrom the normative database or historical data source.

The OCT-based ophthalmic testing center system can be configured tooutput the results of and/or data from the photostress response timetest. For example, the results can be outputted directly to the subjectin a hardcopy (for example, printed card or paper) or electronic format(for example, on a display, via email, text messaged, or in a magneticstrip), stored locally on the device or on an attached computer,transmitted to a central database, or transmitted directly to theordering or related physician.

Contrast Sensitivity Test

With reference to FIG. 43, in general contrast sensitivity is afunctional parameter that can indicate the presence of macular diseaseand/or progression of diseases, for example, age-related maculardegeneration. Subjects with contrast sensitivity generally havedifficulty distinguishing objects of similar contrast.

In reference to FIG. 43, the OCT-based ophthalmic testing center systemcan be configured to conduct a contrast sensitivity test by presentingobjects to subjects having various contrast, for example, charts havingcircles with bars of alternating grays and/or specific orientations thatcan be identified by the user. In various embodiments, the OCT-basedophthalmic testing center system can be configured to use the samemethodologies described previously for visual acuity testing except withmodification of the contrast between letters and/or numbers and/or thebackground and/or between bars or lines on the optokinetic stimuli. TheOCT-based ophthalmic testing center system can be configured to controlthe optical distance between the subject's eye and the fixation targetsby adjusting the vergence of the light from the fixation display (forexample, by collimation or divergence). For example, the opticaldistance could be set at 14 inches to simulate reading, 30 inches tosimulate computer use, 20 feet to equate with conventional visual acuitymeasurements, infinity, or at any other distance. As discussedpreviously, the OCT-based ophthalmic testing center system can beconfigured to correct for refractive error at the various opticaldistances. In various embodiments, the OCT-based ophthalmic testingcenter system can be configured to use previously generated visualacuity results and/or other test data results as a starting point forcontrast-based measurements. For example, the OCT-based ophthalmictesting center system can be configured to display a stimulus and/orimage having light gray and/or dark gray bars instead of using black andwhite bars. FIG. 43 illustrates one embodiment of an image 4301Acomprising bars of three varying contrasts (the hatched bar representinga middle contrast) and one image 4301B illustrating another embodimentof an image comprising bars of two varying contrasts (for example, lightgray and dark gray or black and white). In various embodiments, theOCT-based ophthalmic testing center system can be configured to conductthe contrast sensitivity test using a variety of stimuli sizes,frequencies, and/or velocities. In various embodiments, the results fromthe contrast sensitivity test could be a multitude of visual acuitymeasurements at various contrast and color settings.

With reference to FIG. 43, in various embodiments the OCT-basedophthalmic testing center system can be configured to instruct (visuallyand/or audibly) the subject to look at the image and/or stimuli beingpresented on the display devices of the OCT-based ophthalmic testingcenter system. In various embodiments, the OCT-based ophthalmic testingcenter system can be configured to instruct (visually and/or audibly)the subject to either press a button and/or respond verbally by saying‘Yes’ and/or the letter shown in the image when appreciated or perceivedby the subject. Button presses and/or verbal response can be stored bythe OCT-based ophthalmic testing center system for tabulation and/oranalysis. The OCT-based ophthalmic testing center system can beconfigured to capture these verbalizations or verbal responses using theOCT-based ophthalmic testing center system's microphone input, and theseverbalizations or voice responses can be processed using the OCT-basedophthalmic testing center system's CPU and speech recognition softwareto determine the nature and/or accuracy of the response, for example,did the subject say the correct letter shown in the image.

With reference to FIG. 43, measurements made with the contrastsensitivity test can include, but are not be limited to, the lowestcontrast at which objects, such as bars, can be seen relative to theirbackgrounds; the parameters, such as spatial frequency, for the objectsin each location to be seen by the subject; or incremented scores ofvalues, such as 0.05 log units for each correctly answered letter. TheOCT-based ophthalmic testing center system can be configured to tabulateand/or store the results of the contrast sensitivity test. In variousembodiments, the OCT-based ophthalmic testing center can be configuredto output a report and/or graphical representation of the tabulatedresults of the contrast sensitivity test. For example, the graph 4302illustrates a line graphs displaying the measurements of a contrastsensitivity test conducted by the OCT-based ophthalmic testing centersystem. In the example, the graph 4302 illustrates contrast percentageversus letter size (using standard visual acuity designations). A user,subject, and/or patient associated with these contrast sensitivityresults cannot generally see small letters without higher contrast. Ingeneral, users, subjects, and/or patients associated with graphs withsubstantially flat slopes can see any size letter in any contrast level.Other measurements and analyses are possible. If processed in real-time,the OCT-based ophthalmic testing center system can be configured to usethese data to augment additional test stimuli presented to the subject.

With reference to FIG. 43, in various embodiments, the OCT-basedophthalmic testing center system can be configured to compare thecontrast sensitivity test data to a normative database to determinepatterns of deviation and/or generate risk assessments and/or clinicalreports. In various embodiments, the OCT-based ophthalmic testing centersystem can be configured to analyze, compare, and/or add the contrastsensitivity test data to other data, such as the subject's ophthalmichistory data that is stored on a subject's input card or retrieved froma historical database or other history-taking modules incorporated intothe OCT-based ophthalmic testing center system. In various embodiments,the OCT-based ophthalmic testing center system can be configured toautomatically conduct a contrast sensitivity test based on ophthalmichistory. For example, if the subject complains of distorted vision orthe like, the OCT-based ophthalmic testing center system can beconfigured to record and/or store such information so that the OCT-basedophthalmic testing center system can be configured to automaticallyperform a contrast sensitivity test based on the record. In anotherexample, if the patient has a family history of contrast sensitivityissues or the like, and such information is stored within the subject'sophthalmic history database, the OCT-based ophthalmic testing centersystem can be configured to automatically perform a contrast sensitivitytest. The OCT-based ophthalmic testing center system can be configuredto generate various statistics based on the measured contrastsensitivity test data, which may be combined with data from thenormative database or historical data source.

With reference to FIG. 43, the OCT-based ophthalmic testing centersystem can be configured to output the results of and/or data from thecontrast sensitivity test. For example, the results can be outputteddirectly to the subject in a hardcopy (for example, printed card orpaper) or electronic format (for example, on a display, via email, textmessaged, or in a magnetic strip), stored locally on the device or on anattached computer, transmitted to a central database, or transmitteddirectly to the ordering or related physician.

Fixation Stability Test

With reference to FIG. 44, in general, fixation stability is adiagnostic test that can be correlated with underlying function.Subjects with good vision are generally able to hold steady fixation ona small target without losing track of the target and/or wandering toofar afield from the target. Subjects with poor visual acuity generallyhave more difficulty seeing small targets and/or may have many points ofequally good vision in their eye (for example, the small area with thebest vision is apparently damaged), which causes their fixation tomeander.

In reference to FIG. 44, in various embodiments, the OCT-basedophthalmic testing center system can be configured to conduct fixationstability testing, which generally is a functional test that can employeye tracking methodologies, for example, tracking the fovea using fovealverification and/or foveal location. The OCT-based ophthalmic testingcenter system can be configured to conduct fixation stability testing ineither a self-operated or self-administered fashion, or in an assistedfashion with someone other than the subject either partially orcompletely administers the test. The fixation stability test can beperformed on both eyes simultaneously (a binocular examination) or firston one eye and then on the other eye. The OCT-based ophthalmic testingcenter system can comprise display devices configured to displaystationary fixation targets, for example, dots, crosses, circles orother images. The OCT-based ophthalmic testing center system can beconfigured to control the optical distance between the subject's eye andthe fixation targets by adjusting the vergence of the light from thefixation display (for example, by collimation or divergence). Forexample, the optical distance could be set at 14 inches to simulatereading, 30 inches to simulate computer use, 20 feet to equate withconventional visual acuity measurements, infinity, or at any otherdistance. As discussed previously, the OCT-based ophthalmic testingcenter system can be configured to correct for refractive error at thevarious optical distances.

With reference to FIG. 44, to conduct the fixation stability test, theOCT-based ophthalmic testing center system can be configured to instruct(visually and/or audibly) the subject to focus on the fixation targetfor a period of time while the OCT-based ophthalmic testing centersystem tracks the movement of the eye(s) during the period. In variousembodiments, the OCT-based ophthalmic testing center system can beconfigured to conduct the fixation stability testing by presenting thesubject with a steady target and instructing the subject to maintainsteady fixation while simultaneously capturing high speed, small 3D-OCTscans or sparse 3D-OCT scans across the fundus as described herein. TheOCT-based testing center system can be configured to capture and/orrecord relative movements and/or movements relative to the startingposition of the fundus as a point cloud 4401, 4402 of intervalmovements. In various embodiments, the OCT-based ophthalmic testingcenter system can be configured to monitor and/or track the subject'sgaze or the direction of the subject's eyes with non-OCT imagingmodalities by tracking detectable structures within the eye, forexample, the fovea or other features or sets of features with unique oridentifiable patterns of intensity. Non-OCT imaging modalities include,without limitation, infrared (IR) imaging or scanning laserophthalmoscopy (SLO) imaging. The OCT-based ophthalmic testing centersystem can also be configured to monitor the subject's gaze by trackingdetectable structures within the eye using small 3D-OCT scans centeredunder the image of the fixation target on the retina. In variousembodiments, the OCT-based ophthalmic testing center system can beconfigured to use foveal verification in cases where the foveal locationmay be known or closely approximated, and/or the OCT-based ophthalmictesting center system can be configured to use foveal location when thefovea cannot be located. For subjects suffering from retinal disease,the OCT-based ophthalmic testing center system can be configured totrack other non-foveal detectable structures with OCT to the subject'sfixation stability during the fixation stability test. Variousstatistics could be calculated from this point cloud including totaldistance moved per unit time, average distance from centroid, standarddeviation of interval movements, or the like. Other measurements and/oranalyses are possible.

In reference to FIG. 44, in various embodiments, other analyses cancomprise edge detection of the vitreoretinal interface to detect thefoveal depression, edge detection of the vitreoretinal interface andretinal pigment epithelium (RPE) to determine retinal thickness, edgedetection of other retinal features, or topographic or thickness slopecalculations followed by 2D registration to previous maps, among otheranalyses. In the absence of a foveal or optic nerve depression, theOCT-based ophthalmic testing center system can be configured to userelative slopes of the retinal surface to determine and/or indicate eyemovement away from either the past fundus position or the position atthe start of the test.

With reference to FIG. 44, in various embodiments, the OCT-basedophthalmic testing center system can be configured to compare thefixation stability test data to a normative database to determinepatterns of deviation and/or generate risk assessments and/or clinicalreports. In various embodiments, the OCT-based ophthalmic testing centersystem can be configured to analyze, compare, and/or add the fixationstability test data to other data, such as the subject's ophthalmichistory data that is stored on a subject's input card or retrieved froma historical database or other history-taking modules incorporated intothe OCT-based ophthalmic testing center system. In various embodiments,the OCT-based ophthalmic testing center system can be configured toautomatically conduct a fixation stability test based on ophthalmichistory. For example, if the subject has a history of fixationinstability or the like, the OCT-based ophthalmic testing center systemcan be configured to record and/or store such information so that theOCT-based ophthalmic testing center system can be configured toautomatically perform a fixation stability test based on the record. Inanother example, if the patient has a complaint of blurred vision or thelike, and such information is stored within the subject's ophthalmichistory database, the OCT-based ophthalmic testing center system can beconfigured to automatically perform a fixation stability test. TheOCT-based ophthalmic testing center system can be configured to generatevarious statistics based on the measured fixation stability test data,which may be combined with data from the normative database orhistorical data source.

In reference to FIG. 44, in various embodiments, the OCT-basedophthalmic testing center system can be configured to output the resultsof and/or data from the fixation stability test. For example, theresults can be outputted directly to the subject in a hardcopy (forexample, printed card or paper) or electronic format (for example, on adisplay, via email, text messaged, or in a magnetic strip), storedlocally on the device or on an attached computer, transmitted to acentral database, or transmitted directly to the ordering or relatedphysician.

Perimetry—Confrontation Visual Field Test

With reference to FIG. 45, FIG. 46 and FIG. 47, in general, perimetry,or visual field testing, can be divided into several categories. Oneform of perimetry is called confrontation visual fields. In variousembodiments, the OCT-based ophthalmic testing center system can beconfigured to conduct confrontation visual fields testing, which isgenerally a functional test that can employ eye tracking methodologies,for, example, tracking the fovea using foveal verification and/or foveallocation.

In reference to FIG. 45, in various embodiments, the OCT-basedophthalmic testing center system can be configured to conductconfrontation visual fields testing in either a self-operated orself-administered fashion, or in an assisted fashion with someone otherthan the subject either partially or completely administers the test.The confrontation visual fields test can be performed on both eyessimultaneously (a binocular examination) or, first on one eye and thenon the other eye. The OCT-based ophthalmic testing center system cancomprise display devices configured to first display stationary fixationtargets 4508, for example, dots, crosses, circles, or the like. TheOCT-based ophthalmic testing center system can be configured to controlthe optical distance between the subject's eye and the fixation targetsby adjusting the vergence of the light from the fixation display (forexample, by collimation or divergence). For example, the opticaldistance could be set at 14 inches to simulate reading, 30 inches tosimulate computer use, 20 feet to equate with conventional visual acuitymeasurements, infinity, or at any other distance. As discussedpreviously, the OCT-based ophthalmic testing center system can beconfigured to correct for refractive error at the various opticaldistances.

With reference to FIG. 45, the OCT-based ophthalmic testing centersystem can be configured to conduct confrontation visual fields testingby displaying and/or presenting transient objects 4502, for example,dots, letters, numbers, or the like, of varying intensity, size, colorand contrast, that can be displayed in, for example, one of six or morelocations 4504 around the subject's visual field 4506. In variousembodiments the OCT-based ophthalmic testing center system can beconfigured to instruct (visually and/or audibly) the subject to lookstraight at the fixation targets 4508 throughout the examination and/orto either press a button and/or respond verbally by saying ‘Yes’ or thelike when a transient stimulus/object is appreciated or perceived by thesubject. If transient stimuli/objects, for example, a dot, is displayed,the OCT-based ophthalmic testing center system can be configured toexpect a button press and/or can be configured to store the response fortabulation. If transient stimuli/objects, for example, numbers orletters, are displayed, the OCT-based ophthalmic testing center systemcan be configured to expect verbal responses and/or can be configured toreceive using a microphone input within and/or connected to theOCT-based ophthalmic testing center system device and/or processed bysoftware, for example, speech recognition software, to determine theaccuracy of the response.

To ensure that the subject is not merely looking at peripheral areas ofthe display device with their central vision but rather is using thesubject's peripheral vision to detect and/or perceive the stimuli, theOCT-based ophthalmic testing center system can be configured to monitorand/or track the subject's gaze or the direction of the subject's eyeswith non-OCT imaging modalities by tracking detectable structures withinthe eye, for example, the fovea or other features or sets of featureswith unique or identifiable patterns of intensity. Non-OCT imagingmodalities include without limitation infrared (IR) imaging or scanninglaser ophthalmoscopy (SLO) imaging. The OCT-based ophthalmic testingcenter system can also be configured to monitor the subject's gaze bytracking detectable structures within the eye using small 3D-OCT scanscentered under the image of the central fixation target on the retinaand/or by using sparse 3D-OCT scans across the fundus. In variousembodiments, the OCT-based ophthalmic testing center system can beconfigured to use foveal verification in cases where the foveal locationmay be known or closely approximated, and/or the OCT-based ophthalmictesting center system can be configured to use foveal location when thefovea cannot be located. For subjects suffering from retinal disease,the OCT-based ophthalmic testing center system can be configured totrack other non-foveal detectable structures with OCT to ensure theirpositions are unchanged during the confrontation visual fields test.

In reference to FIG. 45, in various embodiments, the OCT-basedophthalmic testing center system can be configured to conduct the eyetracking scans before each stimulus is presented to the subject, and/oranalyzed either after completion of the entire test to develop a testreliability score. In various embodiments, the eye tracking scans arecompleted in real-time during the confrontation visual fields test sothat presentation of the stimulus can be contingent upon centralfixation. This analysis can comprise edge detection of the vitreoretinalinterface to detect the foveal depression, edge detection of thevitreoretinal interface and retinal pigment epithelium (RPE) todetermine retinal thickness, edge detection of other retinal features,or topographic or thickness slope calculations followed by 2Dregistration to previous maps, among other analyses. If the subject isfound to be looking away from the central fixation target, the OCT-basedophthalmic testing center system can be configured to verbally orvisually remind the subject to look at the fixation target. TheOCT-based ophthalmic testing center system can be configured to withholdstimuli if the fovea is not found to be located centrally or an eyemovement is discovered by comparison of other retinal features betweenstimuli. In various embodiments, the OCT-based ophthalmic testing centersystem can be configured to turn off a stimulus if it senses eyemovement during stimulus display and movement. In the absence of afoveal or optic nerve depression, the OCT-based ophthalmic testingcenter system can be configured to use relative slopes of the retinalsurface to determine and/or indicate eye movement away from either thepast fundus position or the position at the start of the test.

With reference to FIG. 45, measurements made with the confrontationvisual fields test can include, but are not be limited to, a visualfield map indicating the accuracy of responses in all displayedlocations, the parameters for the stimuli required in each location tobe seen by the subject, the number of positive responses for displayedstimuli (true positives), the number of positive responses forundisplayed stimuli or stimuli intended to fall into the physiologicblind spot (false positives), and the number of failed responses fordisplayed stimuli (false negatives). Other measurements and analyses arepossible. If processed in real-time, the OCT-based ophthalmic testingcenter system can be configured to use these data to augment additionaltest stimuli presented to the subject.

With reference to FIG. 45, in various embodiments, the OCT-basedophthalmic testing center system can be configured to compare theconfrontation visual fields test data to a normative database todetermine patterns of deviation and/or generate risk assessments and/orclinical reports. In various embodiments, the OCT-based ophthalmictesting center system can be configured to analyze, compare, and/or addthe confrontation visual fields test data to other data, such as thesubject's ophthalmic history data that is stored on a subject's inputcard or retrieved from a historical database or other history-takingmodules incorporated into the OCT-based ophthalmic testing centersystem. In various embodiments, the OCT-based ophthalmic testing centersystem can be configured to automatically conduct a confrontation visualfields test based on ophthalmic history. For example, if the subject hasglaucoma or the like, the OCT-based ophthalmic testing center system canbe configured to record and/or store such information so that theOCT-based ophthalmic testing center system can be configured toautomatically perform a confrontation visual fields test based on therecord. In another example, if the patient has a family history ofglaucoma or the like, and such information is stored within thesubject's ophthalmic history database, the OCT-based ophthalmic testingcenter system can be configured to automatically perform a confrontationvisual fields test. The OCT-based ophthalmic testing center system canbe configured to generate various statistics based on the measuredconfrontation visual fields test data, which may be combined with datafrom the normative database or historical data source.

With reference to FIG. 45, the OCT-based ophthalmic testing centersystem can be configured to output the results of and/or data from theconfrontation visual fields test. For example, the results can beoutputted directly to the subject in a hardcopy (for example, printedcard or paper) or electronic format (for example, on a display, viaemail, text messaged, or in a magnetic strip), stored locally on thedevice or on an attached computer, transmitted to a central database, ortransmitted directly to the ordering or related physician.

Kinetic Perimetry Test

With reference to FIG. 46, in general, kinetic perimetry is a test usedfor monitoring of neurologic, neuro-ophthalmic, degenerative and/orcongenital ophthalmic conditions. In various embodiments, the OCT-basedophthalmic testing center system can be configured to conduct kineticperimetry testing, which is generally a functional test that can employeye tracking methodologies, for example, tracking the fovea using fovealverification and/or foveal location. The OCT-based ophthalmic testingcenter system can conduct the kinetic perimetry testing in either aself-operated or self-administered fashion, or in an assisted fashionwith someone other than the subject either partially or completelyadministering the test. The kinetic perimetry test can be performed onboth eyes simultaneously (a binocular examination) or, first on one eyeand then on the other eye. The OCT-based ophthalmic testing centersystem can comprise display devices configured to first displaystationary fixation targets 4602, for example, dots, crosses, circles,and/or the like. The OCT-based ophthalmic testing center system can beconfigured to control the optical distance between the subject's eye andthe fixation targets by adjusting the vergence of the light from thefixation display (for example, by collimation or divergence). Forexample, the optical distance could be set at 14 inches to simulatereading, 30 inches to simulate computer use, 20 feet to equate withconventional visual acuity measurements, infinity, or at any otherdistance. As discussed previously, the OCT-based ophthalmic testingcenter system can be configured to correct for refractive error at thevarious optical distances.

In reference to FIG. 46, the OCT-based ophthalmic testing center systemcan be configured to conduct the kinetic perimetry test by displayingand/or presenting transient objects 4604, for example, dots or the like,in various locations around the subject's visual field 4605. In variousembodiments, the OCT-based ophthalmic testing center system can beconfigured to present the transient objects in varying intensity, size,color and contrast that can be shown to move, typically from theperiphery to the center 4606, but also from the center to periphery inthe case of blindspot testing. For example, in some embodiments, thetransient objects 4606 can be presented as light objects on a darkerfield 4605 and in other embodiments, the transient objects 4606 can bepresented as dark objects on a lighter field 4605. In variousembodiments, the OCT-based ophthalmic testing center system can beconfigured to instruct (visually and/or audibly) the subject to lookstraight at the fixation targets throughout the examination and toeither press a button and/or respond verbally by saying a ‘Yes’ when atransient stimulus is appreciated or perceived by the subject. Buttonpresses and/or verbal response can be stored by the OCT-based ophthalmictesting center system for tabulation and/or analysis. The OCT-basedophthalmic testing center system can be configured to capture theseverbalizations or verbal responses using the OCT-based ophthalmictesting center system's microphone input, and these verbalizations orvoice responses can be processed using the OCT-based ophthalmic testingcenter system's CPU and speech recognition software to determine thenature of the response.

To ensure that the subject is not merely looking at peripheral areas ofthe vision area but rather is using the subject's peripheral vision todetect and/or perceive the stimuli, the OCT-based ophthalmic testingcenter system can be configured to monitor and/or track the subject'sgaze or the direction of the subject's eyes with non-OCT imagingmodalities by tracking detectable structures within the eye, forexample, the fovea or other features or sets of features with unique oridentifiable patterns of intensity. Non-OCT imaging modalities includewithout limitation infrared (IR) imaging or scanning laserophthalmoscopy (SLO) imaging. The OCT-based ophthalmic testing centersystem can also be configured to monitor the subject's gaze by trackingdetectable structures within the eye using small 3D-OCT centered underthe image of the central fixation target on the retina and/or by usingsparse 3D-OCT scans across the fundus. In various embodiments, theOCT-based ophthalmic testing center system can be configured to usefoveal verification in cases where the foveal location may be known orclosely approximated, and/or the OCT-based ophthalmic testing centersystem can be configured to use foveal location when the fovea cannot belocated. For subjects suffering from retinal disease, the OCT-basedophthalmic testing center system can be configured to track othernon-foveal detectable structures with OCT to ensure their positions areunchanged during the kinetic perimetry test.

In various embodiments, the OCT-based ophthalmic testing center systemcan be configured to conduct the eye tracking scans before each stimulusis presented to the subject, and/or analyzed either after completion ofthe entire test to develop a test reliability score. In variousembodiments, the eye tracking scans are completed in real-time duringthe kinetic perimetry test so that presentation of the stimulus would becontingent upon central fixation. This analysis can comprise edgedetection of the vitreoretinal interface to detect the fovealdepression, edge detection of the vitreoretinal interface and retinalpigment epithelium (RPE) to determine retinal thickness, edge detectionof other retinal features, or topographic or thickness slopecalculations followed by 2D registration to previous maps, among otheranalyses. If the subject is found to be looking away from the centralfixation target, the OCT-based ophthalmic testing center system can beconfigured to verbally or visually remind the subject to look at thefixation target. The OCT-based ophthalmic testing center system can beconfigured to withhold stimuli if the fovea is not found to be locatedcentrally or an eye movement is discovered by comparison of otherretinal features between stimuli. In various embodiments, the OCT-basedophthalmic testing center system can be configured to turn off astimulus if it sensed eye movement during stimulus display and movement.In the absence of a foveal or optic nerve depression, the OCT-basedophthalmic testing center system can be configured to use relativeslopes of the retinal surface to determine and/or indicate eye movementaway from either the past fundus position or the position at the startof the test.

With reference to FIG. 46, measurements made with the kinetic perimetrytest can include, but are not be limited to, a visual field mapindicating the accuracy of responses in all displayed locations, theparameters for the stimuli required in each location to be seen by thesubject, the number of positive responses for displayed stimuli (truepositives), the number of positive responses for undisplayed stimuli orstimuli intended to fall into the physiologic blind spot (falsepositives), and the number of failed responses for displayed stimuli(false negatives). Other measurements and analyses are possible. Ifprocessed in real-time, the OCT-based ophthalmic testing center systemcan be configured to use these data to augment additional test stimulipresented to the subject.

With reference to FIG. 46, in various embodiments, the OCT-basedophthalmic testing center system can be configured to compare thekinetic perimetry test data to a normative database to determinepatterns of deviation and/or generate risk assessments and/or clinicalreports. In various embodiments, the OCT-based ophthalmic testing centersystem can be configured to analyze, compare, and/or add the kineticperimetry test data to other data, such as the subject's ophthalmichistory data that is stored on a subject's input card or retrieved froma historical database or other history-taking modules incorporated intothe OCT-based ophthalmic testing center system. In various embodiments,the OCT-based ophthalmic testing center system can be configured toautomatically conduct a kinetic perimetry test based on ophthalmichistory. For example, if the subject complains of night blindness, theOCT-based ophthalmic testing center system can be configured to recordand/or store such information so that the OCT-based ophthalmic testingcenter system can be configured to automatically perform a kineticperimetry test based on the recorded complaint. In another example, ifthe patient has a family history of inherited retinal blindness or thelike, and such information is stored within the subject's ophthalmichistory database, the OCT-based ophthalmic testing center system can beconfigured to automatically perform a kinetic perimetry test. TheOCT-based ophthalmic testing center system can be configured to generatevarious statistics based on the measured kinetic perimetry test data,which may be combined with data from the normative database orhistorical data source.

With reference to FIG. 46, the OCT-based ophthalmic testing centersystem can be configured to output the results of and/or data from thekinetic perimetry test. For example, the results can be outputteddirectly to the subject in a hardcopy (for example, printed card orpaper) or electronic format (for example, on a display, via email, textmessaged, or in a magnetic strip), stored locally on the device or on anattached computer, transmitted to a central database, or transmitteddirectly to the ordering or related physician.

Static Perimetry Test

With reference to FIG. 47, in general static perimetry is a test forglaucoma monitoring. In various embodiments, the OCT-based ophthalmictesting center system can be configured to conduct static perimetrytesting, which is generally a functional test that can employ eyetracking methodologies, for example, tracking the fovea using fovealverification and/or foveal location. In reference to FIG. 47, in variousembodiments, the OCT-based ophthalmic testing center system can beconfigured to conduct static perimetry testing in either a self-operatedor self-administered fashion, or in an assisted fashion with someoneother than the subject either partially or completely administers thetest. The perimetry test can be performed on both eyes simultaneously (abinocular examination) or, first on one eye and then on the other eye.The OCT-based ophthalmic testing center system can comprise displaydevices that can be configured to first display stationary fixationtargets, for example, dots, crosses, circles, or the like. The OCT-basedophthalmic testing center system can be configured to control theoptical distance between the subject's eye and the fixation targets byadjusting the vergence of the light from the fixation display (forexample, by collimation or divergence). For example, the opticaldistance could be set at 14 inches to simulate reading, 30 inches tosimulate computer use, 20 feet to equate with conventional visual acuitymeasurements, infinity, or at any other distance. As discussedpreviously, the OCT-based ophthalmic testing center system can beconfigured to correct for refractive error at the various opticaldistances.

With reference to FIG. 47, the OCT-based ophthalmic testing centersystem can be configured to conduct static perimetry testing bydisplaying and/or presenting transient objects 4702, for example, dots,of varying intensity, size, color, contrast, or the like, that can bedisplayed in various locations around the subject's visual field 4704.In various embodiments the OCT-based ophthalmic testing center systemcan be configured to instruct (visually and/or audibly) the subject tolook straight at the fixation targets 4706 throughout the examinationand/or to either press a button and/or respond verbally by saying ‘Yes’when a transient stimulus/object is appreciated or perceived by thesubject. Button presses and/or verbal response can be stored by theOCT-based ophthalmic testing center system for tabulation and/oranalysis. The OCT-based ophthalmic testing center system can beconfigured to capture these verbalizations or verbal responses using theOCT-based ophthalmic testing center system's microphone input, and theseverbalizations or voice responses can be processed using the OCT-basedophthalmic testing center system's CPU and speech recognition softwareto determine the nature of the response. To ensure that the subject isnot merely looking directly at peripheral areas of the display devicebut rather is using the subject's peripheral vision to detect and/orperceive the stimuli, the OCT-based ophthalmic testing center system canbe configured to monitor and/or track the subject's gaze or thedirection of the subject's eyes with non-OCT imaging modalities bytracking detectable structures within the eye, for example, the fovea orother features or sets of features with unique or identifiable patternsof intensity. Non-OCT imaging modalities include without limitationinfrared (IR) imaging or scanning laser ophthalmoscopy (SLO) imaging.The OCT-based ophthalmic testing center system can also be configured tomonitor the subject's gaze by tracking detectable structures within theeye using small 3D-OCT scans centered under the image of the centralfixation target on the retina and/or by using sparse 3D-OCT scans acrossthe fundus. In various embodiments, the OCT-based ophthalmic testingcenter system can be configured to use foveal verification in caseswhere the foveal location may be known or closely approximated, and/orthe OCT-based ophthalmic testing center system can be configured to usefoveal location when the fovea cannot be located. For subjects sufferingfrom retinal disease, the OCT-based ophthalmic testing center system canbe configured to track other non-foveal detectable structures with OCTto ensure their positions are unchanged during the static perimetrytest.

In reference to FIG. 47, in various embodiments, the OCT-basedophthalmic testing center system can be configured to conduct the eyetracking scans before each stimulus is presented to the subject, and/oranalyzed either after completion of the entire test to develop a testreliability score. In various embodiments, the eye tracking scans arecompleted in real-time during the static perimetry test so thatpresentation of the stimulus would be contingent upon central fixation.This analysis can comprise edge detection of the vitreoretinal interfaceto detect the foveal depression, edge detection of the vitreoretinalinterface and retinal pigment epithelium (RPE) to determine retinalthickness, edge detection of other retinal features, or topographic orthickness slope calculations followed by 2D registration to previousmaps, among other analyses. If the subject is found to be looking awayfrom the central fixation target, the OCT-based ophthalmic testingcenter system can be configured to verbally or visually remind thesubject to look at the fixation target. The OCT-based ophthalmic testingcenter system can be configured to withhold stimuli if the fovea is notfound to be located centrally or an eye movement is discovered bycomparison of other retinal features between stimuli. In variousembodiments, the OCT-based ophthalmic testing center system can beconfigured to turn off a stimulus if it senses eye movement duringstimulus display and movement. In the absence of a foveal or optic nervedepression, the OCT-based ophthalmic testing center system can beconfigured to use relative slopes of the retinal surface to determineand/or indicate eye movement away from either the past fundus positionor the position at the start of the test.

With reference to FIG. 47, measurements made with the static perimetrytest can include, but are not be limited to, a visual field mapindicating the accuracy of responses in all displayed locations, theparameters for the stimuli required in each location to be seen by thesubject, the number of positive responses for displayed stimuli (truepositives), the number of positive responses for undisplayed stimuli orstimuli intended to fall into the physiologic blind spot (falsepositives), and the number of failed responses for displayed stimuli(false negatives). Other measurements and analyses are possible. Ifprocessed in real-time, the OCT-based ophthalmic testing center systemcan be configured to use these data to augment additional test stimulipresented to the subject.

With reference to FIG. 47, in various embodiments, the OCT-basedophthalmic testing center system can be configured to compare the staticperimetry test data to a normative database to determine patterns ofdeviation and/or generate risk assessments and/or clinical reports. Invarious embodiments, the OCT-based ophthalmic testing center system canbe configured to analyze, compare, and/or add the static perimetry testdata to other data, such as the subject's ophthalmic history data thatis stored on a subject's input card or retrieved from a historicaldatabase or other history-taking modules incorporated into the OCT-basedophthalmic testing center system. In various embodiments, the OCT-basedophthalmic testing center system can be configured to automaticallyconduct a static perimetry test based on ophthalmic history. Forexample, if the subject has glaucoma or the like, the OCT-basedophthalmic testing center system can be configured to record and/orstore such information so that the OCT-based ophthalmic testing centersystem can be configured to automatically perform a static perimetrytest based on the record. In another example, if the patient has afamily history of glaucoma or the like, and such information is storedwithin the subject's ophthalmic history database, the OCT-basedophthalmic testing center system can be configured to automaticallyperform a static perimetry test. The OCT-based ophthalmic testing centersystem can be configured to generate various statistics or comparisonsbased on the measured static perimetry test data, which may be combinedwith data from the normative database or historical data source.

With reference to FIG. 47 the OCT-based ophthalmic testing center systemcan be configured to output the results of and/or data from the staticperimetry test. For example, the results can be outputted directly tothe subject in a hardcopy (for example, printed card or paper) orelectronic format (for example, on a display, via email, text messaged,or in a magnetic strip), stored locally on the device or on an attachedcomputer, transmitted to a central database, or transmitted directly tothe ordering or related physician.

Corneal Topography Test

With reference to FIG. 48, in general, corneal topography andkeratometry are used to study the sphericity and regularity of thecorneal surface. Certain corneal disorders, for example, keratoconus orpost-operative astigmatism, may cause the cornea to develop anon-spherical shape. In addition, the corneal curvature and power areused to predict the power of the intraocular lens needed forimplantation during cataract surgery.

In reference to FIG. 48, the OCT-based ophthalmic testing center systemcan be configured to conduct corneal topography testing, which isgenerally a structural test that can employ OCT biomicroscopy. Invarious embodiments, the OCT-based ophthalmic testing center system canbe configured to conduct corneal topography testing in either aself-operated or self-administered fashion, or in an assisted fashionwith someone other than the subject either partially or completelyadministers the test. The corneal topography test can be performed onboth eyes simultaneously (a binocular examination) or first on one eyeand then on the other eye. The OCT-based ophthalmic testing centersystem can comprise display devices configured to display stationaryfixation targets, for example, dots, crosses, circles, and/or the like.In various embodiments, the OCT-based ophthalmic testing center systemcan be configured to instruct (visually and/or audibly) the subject tolook straight at the fixation targets throughout the examination. TheOCT-based ophthalmic testing center system can be configured to controlthe optical distance between the subject's eye and the fixation targetsby adjusting the vergence of the light from the fixation display (forexample, by collimation or divergence). For example, the opticaldistance could be set at 14 inches to simulate reading, 30 inches tosimulate computer use, 20 feet to equate with conventional visual acuitymeasurements, infinity, or at any other distance. As discussedpreviously, the OCT-based ophthalmic testing center system can beconfigured to correct for refractive error at the various opticaldistances.

With reference to FIG. 48, the OCT-based ophthalmic testing centersystem can be configured to scan the eye(s) of the subject using variousscan patterns, including but not limited to rapid radial line 4802,circular 4804, point-based 4806 or raster line B-scans obtained whilethe OCT-based ophthalmic testing center system is focused on the corneaand/or anterior chamber or other area. The OCT-based ophthalmic testingcenter system can be configured to use edge detection software routinesand/or methodologies to detect the anterior and posterior cornealinterfaces to determine, for example, average curvatures (keratometry),corneal diameter, dioptric power, cylinder and axis as well astopographic maps that may depict certain pathology, for example,anterior and posterior keratoconus, in greater detail. The OCT-basedophthalmic testing center system can be configured to use the cornealtopography data and measurements of corneal diameter or the like to aidsurgeons in planning surgical procedures. In various embodiments, theOCT-based ophthalmic testing center system can be configured to outputto a physician a recommended surgical plan, including intraocular lenspower calculations, based on comparing the corneal topography data andmeasurements with threshold values associated with appropriate surgicalplans or using known equations, such as SRK II, SRK/T, Holladay I, andHoffer Q, to calculate the appropriate lens power for each eye. For thispurpose, measurements of the axial length of the eye, conducted with theOCT-based ophthalmic testing center system, could also be incorporatedinto these calculations. Other measurements could also be used in thesecalculations.

In reference to FIG. 48, the OCT-based ophthalmic testing center systemcan be configured to generate various statistics, for example, fittingto expected base curves or studying eccentricity, calculated from thecorneal topography data. The OCT-based ophthalmic testing center systemcan conduct analysis and/or measurements of irregularities on theposterior corneal surface to assess the presence of guttata or keraticprecipitates. Other measurements and analyses are possible. If processedin real-time, the OCT-based ophthalmic testing center system can beconfigured to use these data to plan additional scans to be performed.For example, if keratic precipitates were detected by corneal OCT, theOCT-based ophthalmic testing center system could be configured toperform gonioscopy to evaluate the presence of inflammatory cells in theanterior chamber of the eye.

With reference to FIG. 48, in various embodiments, the OCT-basedophthalmic testing center system can be configured to compare thecorneal topography test data to a normative database to determinepatterns of deviation and/or generate risk assessments and/or clinicalreports. In various embodiments, the OCT-based ophthalmic testing centersystem can be configured to analyze, compare, and/or add the cornealtopography test data to other data, such as the subject's ophthalmichistory data that is stored on a subject's input card or retrieved froma historical database or other history-taking modules incorporated intothe OCT-based ophthalmic testing center system. In various embodiments,the OCT-based ophthalmic testing center system can be configured toautomatically conduct a corneal topography test based on ophthalmichistory. For example, if the subject complains of keratoconus-likesymptoms and/or distortions, the OCT-based ophthalmic testing centersystem can be configured to record and/or store such information so thatthe OCT-based ophthalmic testing center system can be configured toautomatically perform a corneal topography test based on the recordedcomplaint. In another example, if the patient has a family history ofkeratoconus, or the like, and such information is stored within thesubject's ophthalmic history database, the OCT-based ophthalmic testingcenter system can be configured to automatically perform a cornealtopography test. The OCT-based ophthalmic testing center system can beconfigured to generate various statistics based on the measured cornealtopography test data, which may be combined with data from the normativedatabase or historical data source.

With reference to FIG. 48, the OCT-based ophthalmic testing centersystem can be configured to output the results of and/or data from thecorneal topography test. For example, the results can be outputteddirectly to the subject in a hardcopy (for example, printed card orpaper) or electronic format (for example, on a display, via email, textmessaged, or in a magnetic strip), stored locally on the device or on anattached computer, transmitted to a central database, or transmitteddirectly to the ordering or related physician.

Corneal Pachymetry Test

With reference to FIG. 49, in general corneal pachymetry is a diagnostictest that determines the thickness of the cornea. Various diseases, forexample Fuchs' dystrophy, lead to blurred vision due to cornealthickening. Central corneal thickness is also measured in patients withpotential glaucoma.

In reference to FIG. 49, the OCT-based ophthalmic testing center systemcan be configured to conduct corneal pachymetry testing, which isgenerally a structural test that can employ OCT biomicroscopy. Invarious embodiments, corneal pachymetry using the OCT-based ophthalmictesting center system can be conducted in either a self-operated orself-administered fashion, or in an assisted fashion with someone otherthan the subject either partially or completely administers the test.The OCT-based ophthalmic testing center system can be configured toperform a corneal pachymetry test without substantially contacting thecornea. The corneal pachymetry test can be performed on both eyessimultaneously (a binocular examination) or first on one eye and then onthe other eye. The OCT-based ophthalmic testing center system cancomprise display devices configured to display stationary fixationtargets, for example, dots, crosses, circles, and/or the like. Invarious embodiments, the OCT-based ophthalmic testing center system canbe configured to instruct (visually and/or audibly) the subject to lookstraight at the fixation targets throughout the examination. TheOCT-based ophthalmic testing center system can be configured to controlthe optical distance between the subject's eye and the fixation targetsby adjusting the vergence of the light from the fixation display (forexample, by collimation or divergence). For example, the opticaldistance could be set at 14 inches to simulate reading, 30 inches tosimulate computer use, 20 feet to equate with conventional visual acuitymeasurements, infinity, or at any other distance. As discussedpreviously, the OCT-based ophthalmic testing center system can beconfigured to correct for refractive error at the various opticaldistances.

With reference to FIG. 49, the OCT-based ophthalmic testing centersystem can be configured to scan the eye(s) of the subject using variousscan patterns, including but not limited to rapid radial line 4902,circular 4904, point-based 4906 or raster line B-scans obtained whilethe OCT-based ophthalmic testing center system is focused on the corneaand/or anterior chamber. The OCT-based ophthalmic testing center systemcan be configured to use edge detection software routines andmethodologies to detect the anterior and posterior corneal interfaces tocalculate the thickness (for example, the difference or distance betweeninterfaces) at particular points. The OCT-based ophthalmic testingcenter system can be configured to use the measured thicknesses tocompile a 2D map 4908 describing the overall corneal thickness. Incertain embodiments, the OCT-based ophthalmic testing center system canbe configured to generate various statistics, for example, total volume,standard deviation of thickness, maximum thickness, or the like, thatmay be outputted and/or reported to the subject and/or a physician.Other measurements and analyses are possible. If processed in real-time,the OCT-based ophthalmic testing center system can be configured to usethese data to plan additional scans to be performed.

With reference to FIG. 49, in various embodiments, the OCT-basedophthalmic testing center system can be configured to compare thecorneal pachymetry test data to a normative database to determinepatterns of deviation and/or generate risk assessments and/or clinicalreports. In various embodiments, the OCT-based ophthalmic testing centersystem can be configured to analyze, compare, and/or add the cornealpachymetry test data to other data, such as the subject's ophthalmichistory data that is stored on a subject's input card or retrieved froma historical database or other history-taking modules incorporated intothe OCT-based ophthalmic testing center system. In various embodiments,the OCT-based ophthalmic testing center system can be configured toautomatically conduct a corneal pachymetry test based on ophthalmichistory. For example, if the subject complains of Fuchs' dystrophy-likesymptoms and/or distortions, the OCT-based ophthalmic testing centersystem can be configured to record and/or store such information so thatthe OCT-based ophthalmic testing center system can be configured toautomatically perform a corneal pachymetry test based on the recordedcomplaint. In another example, if the patient has a family history ofFuchs' dystrophy, or corneal thickening or the like, and suchinformation is stored within the subject's ophthalmic history database,the OCT-based ophthalmic testing center system can be configured toautomatically perform a corneal pachymetry test. The OCT-basedophthalmic testing center system can be configured to generate variousstatistics based on the measured corneal pachymetry test data, which maybe combined with data from the normative database or historical datasource.

With reference to FIG. 49, the OCT-based ophthalmic testing centersystem can be configured to output the results of and/or data from thecorneal pachymetry test. For example, the results can be outputteddirectly to the subject in a hardcopy (for example, printed card orpaper) or electronic format (for example, on a display, via email, textmessaged, or in a magnetic strip), stored locally on the device or on anattached computer, transmitted to a central database, or transmitteddirectly to the ordering or related physician.

Virtual Gonioscopy Test

With reference to FIG. 50 and FIG. 51, gonioscopy is generally a testperformed, usually in the context of glaucoma or suspicion of glaucoma,to inspect the peripheral angle of the eye which cannot be seen withouta contact lens due to an optical phenomenon known as ‘total internalreflection.’

With reference to FIG. 50 and FIG. 51, the OCT-based ophthalmic testingcenter system can be configured to conduct virtual gonioscopy testing,which is generally a structural test that can employ OCT biomicroscopy.In various embodiments, virtual gonioscopy can be conducted by theOCT-based ophthalmic testing center system without anesthetizing an eyeand without placing a contact lens containing mirrors on the cornea 5002of the eye. In various embodiments, the OCT-based ophthalmic testingcenter system can be configured to conduct virtual gonioscopy in eithera self-operated or self-administered fashion, or in an assisted fashionwith someone other than the subject either partially or completelyadministers the test. The virtual gonioscopy test can be performed onboth eyes simultaneously (a binocular examination) or first on one eyeand then on the other eye. The OCT-based ophthalmic testing centersystem can comprise display devices configured to display stationaryfixation targets, for example, dots, crosses, circles, and/or the like.In various embodiments, the OCT-based ophthalmic testing center systemcan be configured to instruct (visually and/or audibly) the subject tolook straight at the fixation targets throughout the examination. TheOCT-based ophthalmic testing center system can be configured to controlthe optical distance between the subject's eye and the fixation targetsby adjusting the vergence of the light from the fixation display (forexample, by collimation or divergence). For example, the opticaldistance could be set at 14 inches to simulate reading, 30 inches tosimulate computer use, 20 feet to equate with conventional visual acuitymeasurements, infinity, or at any other distance. As discussedpreviously, the OCT-based ophthalmic testing center system can beconfigured to correct for refractive error at the various opticaldistances.

In reference to FIG. 50 and FIG. 51, the OCT-based ophthalmic testingcenter system can be configured to scan the eye(s) of the subject usingvarious scan patterns to obtain rapid radial line, circular, point-basedand/or raster line B-scans while the OCT-based ophthalmic testing centersystem is focused on the cornea 5002 and/or anterior chamber 5004 and/orother area of the eye. In various embodiments, the obtained B-scans canbe sufficiently large, for example, 16 mm long with sufficient depth, toimage the entire limbal-to-limbal anterior chamber from the cornea tothe iris without changing the axial focus of the scanning. In variousembodiments, smaller OCT B-scans may be acquired and patched together togenerate a multiple sequential axial 3D-OCT scan to cover the entirelimbal-to-limbal anterior chamber 5004 from the cornea 5002 to the iris5006, or the smaller OCT B-scans may be viewed independently orindividually. From the images generated by the OCT-based ophthalmictesting center system, structures, for example, the trabecular meshwork,the scleral spur, the ciliary body, and other structures, can bevisually identified by a physician, a technician, or an eyecareprovider, and/or manual measurements of various anterior chamber depthmeasurements 5010 and/or various angle geometries 5008 can be made fromthe images. The OCT-based ophthalmic testing center system can beconfigured to automatically and/or semi-automatically generate, develop,and/or measure quantitative measurements, for example, various anteriorchamber depth measurements 5010, angle geometry 5008, the angle openingdistance (AOD) 5102, the trabecular iris angle (TIA) 5104, and thetrabecular iris space area (TISA) 5106, the anterior chamber diameter,and average and maximum lens thickness can also be made automaticallyand/or semi-automatically using software configured to detect the edgesof these structures using edge detection algorithms or the like. Invarious embodiments, the OCT-based ophthalmic testing center system canbe configured to use automated software to measure the depth of variousportions of the anterior chamber and to generate a report showing themeasured data as individual values, or as a set of values or in a 2Dthickness map.

With reference to FIG. 50 and FIG. 51, the OCT-based ophthalmic testingcenter system can be configured to use doppler OCT to detect abnormalblood vessels (neovascularization) on the iris or in the angle. Invarious embodiments, the OCT-based ophthalmic testing center system canbe configured to use polarization-sensitive OCT to further delineateangle structures. From the data obtained from performing a virtualgonioscopy test, the OCT-based ophthalmic testing center system can beconfigured use the data to identify and/or detect and/or quantifyinflammatory syndromes leading to peripheral anterior synechiae. Othermeasurements and analyses are possible. If processed in real-time, theOCT-based ophthalmic testing center system can be configured to usethese data to plan additional scans to be performed. For example, ifperipheral anterior synechiae were detected, the OCT-based ophthalmictesting center system could be configured to automatically performDoppler OCT to look for abnormal blood vessel formation.

With reference to FIG. 50 and FIG. 51, in various embodiments, theOCT-based ophthalmic testing center system can be configured to comparethe virtual gonioscopy test data to a normative database to determinepatterns of deviation and/or generate risk assessments and/or clinicalreports. In various embodiments, the OCT-based ophthalmic testing centersystem can be configured to analyze, compare, and/or add the virtualgonioscopy test data to other data, such as the subject's ophthalmichistory data that is stored on a subject's input card or retrieved froma historical database or other history-taking modules incorporated intothe OCT-based ophthalmic testing center system. In various embodiments,the OCT-based ophthalmic testing center system can be configured toautomatically conduct a virtual gonioscopy test based on ophthalmichistory. For example, if the subject complains of glaucoma-like symptomsand/or distortions, the OCT-based ophthalmic testing center system canbe configured to record and/or store such information so that theOCT-based ophthalmic testing center system can be configured toautomatically perform a virtual gonioscopy test based on the recordedcomplaint. In another example, if the patient has a family history ofglaucoma or the like, and such information is stored within thesubject's ophthalmic history database, the OCT-based ophthalmic testingcenter system can be configured to automatically perform a virtualgonioscopy test. The OCT-based ophthalmic testing center system can beconfigured to generate various statistics based on the measured virtualgonioscopy test data, which may be combined with data from the normativedatabase or historical data source.

With reference to FIGS. 50 and 51, the OCT-based ophthalmic testingcenter system can be configured to output the results of and/or datafrom the virtual gonioscopy test. For example, the results can beoutputted directly to the subject in a hardcopy (for example, printedcard or paper) or electronic format (for example, on a display, viaemail, text messaged, or in a magnetic strip), stored locally on thedevice or on an attached computer, transmitted to a central database, ortransmitted directly to the ordering or related physician.

Color Vision Test

In reference to FIG. 52, and in general, color vision deficits arecommon and may be inherited or acquired. In various embodiments, theOCT-based ophthalmic testing center system can be configured to conducta color vision test on a subject in either a self-operated orself-administered fashion, or in an assisted fashion with someone otherthan the subject either partially or completely administering the test.The color vision test could be performed on both eyes simultaneously or,first on one eye and then on the other eye. The OCT-based ophthalmictesting center system can be configured to control the optical distancebetween the subject's eye and the fixation targets by adjusting thevergence of the light from the fixation display (for example, bycollimation or divergence). For example, the optical distance could beset at 14 inches to simulate reading, 30 inches to simulate computeruse, 20 feet to equate with conventional visual acuity measurements,infinity, or at any other distance. As discussed previously, theOCT-based ophthalmic testing center system can be configured to correctfor refractive error at the various optical distances.

With reference to FIG. 52, in various embodiments, the OCT-basedophthalmic testing center system can comprise display devices configuredto present numeric color plates to the user (for example, Ishiharaplates), wherein a number is presented within a field of dots ofrandomized color and size. The different hatching patterns in FIGS.52A-52C represent different colors, as shown in the legend. For example,the numeric color plate 5202 comprises a circle of dots in shades ofgreen with the number “6” appearing in shades of orange. This coloringscheme can be used to test for protanopia. In another embodiment, thefield can comprise dots in shades of red, orange and/or yellow with animage, figure, or number appearing in shades of green or blue. Forexample, color plate 5204 comprises a blue image 5206 in a circularfield of dots in shades of red. This coloring scheme can be used to testfor deuteranopia. Numerous images with different color combinations andnumbers can be presented to the subject. In various embodiments, thesecolor combinations could be configured to detect various inherited colordeficits, such as achromacy, monochromacy, dichromacy, or anomaloustrichromacy, or they could be configured to detect acquired colordeficiency. Depending on the subject's ability to detect color, thesubject may or may not be able to see the number or other image of onecolor type presented in the field of colored dots of another color type.The OCT-based ophthalmic testing center system can be configured toinstruct (visually and/or audibly) the subject to read these numberswhen visualized. The OCT-based ophthalmic testing center system can beconfigured to capture these verbalizations or verbal responses using theOCT-based ophthalmic testing center system's microphone input, and theseverbalizations or voice responses can be processed using the OCT-basedophthalmic testing center system's CPU and speech recognition softwareto determine the accuracy of reading each of the several numbers. TheOCT-based ophthalmic testing center system can be configured to assignscores to the verbal responses based on the accuracy of the response,and the individual scores can be added up in each eye to generate afinal color vision measurement for each eye.

In reference to FIG. 52, in various embodiments, the OCT-basedophthalmic testing center system can be configured to display in eitheror both eyes of the subject moving fixation targets that arecolor-encoded in the same way as the colored numbers and/or imagesdescribed above but are moving across the field of colored dots.Numerous color combinations could be presented to the subject asdiscrete tests or as continually changing color combinations. In variousembodiments, these color combinations could be configured to detectvarious inherited color deficits, such as monochromacy, dichromacy, oranomalous trichromacy, or they could be configured to detect acquiredcolor deficiency. The OCT-based ophthalmic testing center system can beconfigured to instruct (visually and/or audibly) the subject to followthose moving targets when visualized. The OCT-based ophthalmic testingcenter system can be configured to use small 3D-OCT scans of thesubject's eye(s) in the moving fixation target area on the retina toverify the presence of the fovea. Alternatively, the OCT-basedophthalmic testing center system can be configured to detect movement ofthe retina using either sparse 3D-OCT scans or non-OCT imaging, such aswith infrared (IR) or scanning laser ophthalmoscopy (SLO) imaging, ofthe retina. The OCT-based ophthalmic testing center system can beconfigured to measure color vision by determining the percent of timethat the fovea was detected in the substantially same location as theimage of the fixation target on the retina or the percent of time thatthe trajectory of retinal movement substantially matched the trajectoryof the moving fixation stimulus.

In referring to FIG. 52, in various embodiments, the OCT-basedophthalmic testing center system can be configured to display to thesubject a randomized pattern 5208 of color-coded optokinetic stimuli toconduct the color vision test. Numerous color combinations could bepresented to the subject as discrete tests or as continually changingcolor combinations. In various embodiments, these color combinationscould be configured to detect various inherited color deficits, such asmonochromacy, dichromacy, or anomalous trichromacy, or they could beconfigured to detect acquired color deficiency. In various embodiments,the OCT-based ophthalmic testing center system can be configured toperform the color vision test without any verbal or button pressresponse from the subject. Instead of verbal responses from the subject,foveal movements or the movements of other detectable features, could betracked either with small foveal 3D-OCT scans, non-OCT imagingmodalities, such as IR or SLO, or sparse macular 3D-OCT scans. TheOCT-based ophthalmic testing center system can be configured torecognize that retinal movements with similar frequency and amplitudemeasurements as the optokinetic stimuli would indicate intact colorvision for that particular color subtype. Failure of the fovea (or otherdetectable features) to move in response to these stimuli would indicatefailure to visualize that color combination. Successes and failurescould be tallied after presentation of numerous color combinations todetermine a final color vision score.

In various embodiments, the OCT-based ophthalmic testing center systemcan be configured to compare the color vision test data to a normativedatabase to determine patterns of deviation and/or generate riskassessments and/or clinical reports. In various embodiments, theOCT-based ophthalmic testing center system can be configured to analyze,compare, and/or add the color vision test data to other data, such asthe subject's ophthalmic history data that is stored on a subject'sinput card or retrieved from a historical database or otherhistory-taking modules incorporated into the OCT-based ophthalmictesting center system. In various embodiments, the OCT-based ophthalmictesting center system can be configured to automatically conduct avision test based on ophthalmic history. For example, if the subjectcomplains of color vision loss and/or distortion, the OCT-basedophthalmic testing center system can be configured to record and/orstore such information so that the OCT-based ophthalmic testing centersystem can be configured to automatically perform a color vision testbased on the recorded complaint. In another example, if the patient hasa family history of color blindness or the like, and such information isstored within the subject's ophthalmic history database, the OCT-basedophthalmic testing center system can be configured to automaticallyperform a color vision test. The OCT-based ophthalmic testing centersystem can be configured to generate various statistics based on themeasured color vision test data, which may be combined with data fromthe normative database or historical data source.

With reference to FIG. 52, the OCT-based ophthalmic testing centersystem can be configured to output the results of and/or data from thecolor vision test. For example, the results can be outputted directly tothe subject in a hardcopy (for example, printed card or paper) orelectronic format (for example, on a display, via email, text messaged,or in a magnetic strip), stored locally on the device or on an attachedcomputer, transmitted to a central database, or transmitted directly tothe ordering or related physician.

Central Visual Distortion Test

With reference to FIG. 53, in general, central vision refers to the highresolution vision used to read, recognize faces and see colors. Visionin this area of the retina, known as the macula, may become distorted indiseases such as macular degeneration, epiretinal membranes, and opticnerve problems.

In reference to FIG. 53, the OCT-based ophthalmic testing center systemcan be configured to conduct central visual distortion tests on asubject in either a self-operated or self-administered, or in anassisted fashion with someone other than the subject either partially orcompletely administers the test. The central visual distortion testcould be performed on both eyes simultaneously or, first on one eye andthen on the other eye. The OCT-based ophthalmic testing center systemcan comprise display devices, which can be configured to display grids5302, 5304, 5306, 5308 with central fixation targets and/or dots 5310,5312, 5314, 5316 at their center. The OCT-based ophthalmic testingcenter system can be configured to control the optical distance betweenthe subject's eye and the fixation targets by adjusting the vergence ofthe light from the fixation display (for example, by collimation ordivergence). For example, the optical distance could be set at 14 inchesto simulate reading, 30 inches to simulate computer use, 20 feet toequate with conventional visual acuity measurements, infinity, or at anyother distance. As discussed previously, the OCT-based ophthalmictesting center system can be configured to correct for refractive errorat the various optical distances.

In referring to FIG. 53, the OCT-based ophthalmic testing center systemcan be configured to instruct (visually and/or audibly) the subject tolook straight at the center of the grid or focus on the central fixationtarget or dot throughout the central visual distortion test. Thesubject's gaze or the direction of the subject's eyes can be monitoredwith non-OCT imaging modalities by tracking detectable structures withinthe eye, for example, the fovea or other features or sets of featureswith unique or identifiable patterns of intensity. Non-OCT imagingmodalities include without limitation infrared (IR) imaging or scanninglaser ophthalmoscopy (SLO) imaging. The OCT-based ophthalmic testingcenter system can also be configured to monitor the subject's gazedirection by tracking detectable structures within the eye using small3D-OCT scans centered on the image of the fixation target on the retinaor sparse 3D-OCT scans across the fundus to ensure that their gaze,either demonstrated by a foveal depression under the image of thefixation target or by unchanged locations for other retinal features,remains fixed on the central target. Detectable structures can includewithout limitation the fovea, other depressions or protrusions withinthe eye, or unique or identifiable patterns or combinations ofprotrusions and/or depressions that signify the point of preferredfixation in the retina.

With reference to FIG. 53, the OCT-based ophthalmic testing centersystem can be configured to conduct the eye tracking scans before eachstimulus or grid image is presented to the subject and analyzed aftercompletion of the entire test to develop a reliability score todetermine the reliability of the central visual distortion. In variousembodiments, the reliability is determined by how often the fovea waslocated under the image of the central fixation target or dot or point.In various embodiments, the OCT-based ophthalmic testing center systemcan be configured to conduct reliability testing (for example,determining when the fovea is located under the image of the fixationtarget or dot or point) in real-time or in substantially real-time sothat presentation or display of the stimulus or grid image is presentedto the subject only when the eye(s) is focused on the central fixationtarget or dot.

In referring to FIG. 53, this analysis can comprise edge detection ofthe vitreoretinal interface to detect the foveal depression, edgedetection of the vitreoretinal interface and retinal pigment epithelium(RPE) to determine retinal thickness, edge detection of other retinalfeatures, or topographic or thickness slope calculations followed by 2Dregistration to previous maps, among other analyses. If the subject isfound to be looking away from the central fixation target, the OCT-basedophthalmic testing center system can be configured to verbally and/orvisually remind the subject to look at and/or focus on the centralfixation target. The OCT-based ophthalmic testing center system can beconfigured to withhold or not display the stimuli and/or grid if thefovea is not detected or found to be located centrally or an eyemovement is discovered by comparison of retinal features betweenstimuli. In various embodiments, the OCT-based ophthalmic testing centersystem can be configured to turn off a stimulus if the device sensed eyemovement during stimulus/grid display and movement. In the absence of afoveal or optic nerve depression, the OCT-based ophthalmic testingcenter system can be configured to use the relative slopes of theretinal surface to indicate eye movement away from either the pastfundus position or the position at the start of the central visualdistortion test.

With reference to FIG. 53, in various embodiments, the OCT-based testingcenter system can be configured to instruct (visually and/or audibly)the user to press a button or to say ‘Yes’ whenever the subjectperceives any grid lines in the subject's central visual field aredistorted or wavy. The OCT-based ophthalmic testing center system can beconfigured to display and/or add individual horizontal and/or verticallines of varying color, thickness, and/or contrast to the image untilthe whole area of the grid is covered. By testing for distortion withboth horizontal and/or vertical lines, the OCT-based ophthalmic testingcenter system can be configured to detect and/or identify and/orlocalize the locations of maximal distortion, and the OCT-basedophthalmic testing center system can be configured to map theselocations and/or areas in a 2D map of the eye(s). In variousembodiments, the OCT-based ophthalmic testing center system can beconfigured to use a speaker output and/or a visual display to instructthe user to press a button and/or to say ‘Yes’ whenever a smalldistorted grid is seen or perceived. The OCT-based ophthalmic testingcenter system can be configured to display small grids, instead ofhorizontal and vertical lines, of varying color, thickness, and/orcontrast to either or both eyes. With these inputs, the OCT-basedophthalmic testing center system can be configured to detect, map and/oridentify the areas of greater and/or greatest distortion.

With reference to FIG. 53, measurements made with central visualdistortion test can include, but are not be limited to, a visualdistortion map indicating the presence of responses in all displayedlocations and/or the parameters for the stimuli required in eachlocation to be seen by the subject. Other measurements and/or analysesare possible. If processed in real-time, the OCT-based ophthalmictesting center system can be configured to use these data to augmentadditional test stimuli and/or grids presented to the subject.

With reference to FIG. 53, in various embodiments, the OCT-basedophthalmic testing center system can be configured to compare thecentral visual distortion test data to a normative database to determinepatterns of deviation and/or to generate risk assessments and/orclinical reports. In various embodiments, the OCT-based ophthalmictesting center system can be configured to analyze, compare, and/or addthe central visual distortion test data to other data, such as thesubject's ophthalmic history data that is stored on a subject's inputcard or retrieved from a historical database or other history-takingmodules incorporated into the OCT-based ophthalmic testing centersystem. In various embodiments, the OCT-based ophthalmic testing centersystem can be configured to automatically conduct a central visualdistortion test based on ophthalmic history. For example, if the subjectcomplains of distortions in the peripheral view, the OCT-basedophthalmic testing center system can be configured to record and/orstore such information so that the OCT-based ophthalmic testing centersystem can be configured to automatically perform a central visualdistortion test based on the recorded complaint. In another example, ifthe patient has a family history of peripheral vision issues or thelike, and such information is stored within the subject's ophthalmichistory database, the OCT-based ophthalmic testing center system can beconfigured to automatically perform a central visual distortion test.The OCT-based ophthalmic testing center system can be configured togenerate various statistics based on the measured central visualdistortion data, which may be combined with data from the normativedatabase or historical data source.

With reference to FIG. 53, the OCT-based ophthalmic testing centersystem can be configured to output the results of and/or data from thecentral visual distortion test. For example, the results can beoutputted directly to the subject in a hardcopy (for example, printedcard or paper) or electronic format (for example, on a display, viaemail, text messaged, or in a magnetic strip), stored locally on thedevice or on an attached computer, transmitted to a central database, ortransmitted directly to the ordering or related physician.

Reading Speed Testing

With reference to FIG. 54, in general visual acuity tests may notdescribe the day-to-day visual dysfunction experienced by patients withmacular diseases, for example, age-related macular degeneration or thelike. The speed, cadence and accuracy of reading regular text can be agood measure of small changes in visual function that fall between thelarger Snellen visual acuity categories such as 20/200 and 20/100.Accordingly, it may be preferred to conduct a reading speed test.

In reference to FIG. 54, an OCT-based ophthalmic testing center systemcould accomplish reading speed testing, which is a functional test thatcan employ eye tracking methodologies, for example, tracking the foveausing foveal verification and/or foveal location. In variousembodiments, the reading speed test can be performed by the OCT-basedophthalmic testing center system in either a self-operated orself-administered fashion, or in an assisted fashion with someone otherthan the subject either partially or completely administering the test.This reading speed test could be performed on both eyes simultaneouslyor, first on one eye and then on the other eye. The OCT-based ophthalmictesting center system can comprise display devices, which can beconfigured to present sentences or paragraphs 5402, 5404 using letterswith various fonts, type style, sizes, contrast, color and/orbackgrounds. The OCT-based ophthalmic testing center system can beconfigured to control the optical distance between the subject's eye andthe fixation targets by adjusting the vergence of the light from thefixation display (for example, by collimation or divergence). Forexample, the optical distance could be set at 14 inches to simulatereading, 30 inches to simulate computer use, 20 feet to equate withconventional visual acuity measurements, infinity, or at any otherdistance. As discussed previously, the OCT-based ophthalmic testingcenter system can be configured to correct for refractive error at thevarious optical distances.

In referring to FIG. 54, the OCT-based ophthalmic testing center systemcan be configured to instruct (visually and/or audibly) the subject toread text presented during the reading speed test. The OCT-basedophthalmic testing center system can be configured to capture theseverbalizations or verbal responses using the OCT-based ophthalmictesting center system's microphone input, and these verbalizations orvoice responses can be processed using the OCT-based ophthalmic testingcenter system's CPU and speech recognition software to determine thereading accuracy. The subject's gaze or the direction of the subject'seyes can be monitored with non-OCT imaging modalities by trackingdetectable structures within the eye, for example, the fovea or otherfeatures or sets of features with unique or identifiable patterns ofintensity. Non-OCT imaging modalities include without limitationinfrared (IR) imaging or scanning laser ophthalmoscopy (SLO) imaging.

The OCT-based ophthalmic testing center system can also be configured tomonitor the subject's gaze direction, speed, and/or consistency ofmovement by tracking detectable structures within the eye using small3D-OCT (for example, foveal verification) and/or sparse 3D-OCT (forexample, foveal location) scans across the fundus. In variousembodiments, the OCT-based ophthalmic testing center system can beconfigured to use foveal verification in cases where the foveal locationmay be known or closely approximated, and/or the OCT-based ophthalmictesting center system can be configured to use foveal location when thefovea cannot be located. In general, reading speed tests are ordered forpeople with retinal disease. Accordingly, for subjects suffering fromretinal disease, the OCT-based ophthalmic testing center system can beconfigured to track other non-foveal detectable structures with OCT.

With reference to FIG. 54, other non-foveal detectable structures caninclude without limitation other depressions or protrusions within theeye, or unique or identifiable patterns or combinations of protrusionsand/or depressions that signify the point of preferred fixation in theretina. In various embodiments, this analysis can comprise edgedetection of the vitreoretinal interface to detect the fovealdepression, edge detection of the vitreoretinal interface and retinalpigment epithelium (RPE) to determine retinal thickness, edge detectionof other retinal features, or topographic or thickness slopecalculations followed by 2D registration to previous maps, among otheranalyses. In the absence of a foveal or optic nerve depression, therelative slopes of the retinal surface could be used to indicate eyemovement away from either the past fundus position or the position atthe start of the test.

With reference to FIG. 54, measurements made with the reading speed testcan include, but not be limited to, the total time spent reading a givensentence, the accuracy of word recognition and the kinetics ofretinal/eye movements. Other measurements and analyses are alsopossible. If processed in real-time, the OCT-based ophthalmic testingcenter system can be configured to use the reading speed test data inconjunction with or to augment additional test stimuli presented to thesubject. For example, if the subject demonstrates uncertainty in readingthe letters displayed, the OCT-based ophthalmic testing center systemdevice can be configured to switch the font of the content, for examplefrom script to a Times New Roman, to see if that is easier for thesubject to see. If not, the device could present the paragraph usinglarger letters than are typically used in standard testing. In variousembodiments, the OCT-based ophthalmic testing center system can beconfigured to compare the reading speed test data to a normativedatabase to determine patterns of deviation and/or generate riskassessments and/or clinical reports. In various embodiments, theOCT-based ophthalmic testing center system can be configured to analyze,compare, and/or add the reading speed test data to other data, such asthe subject's ophthalmic history data that is stored on a subject'sinput card or retrieved from a historical database or otherhistory-taking modules incorporated into the OCT-based ophthalmictesting center system. The OCT-based ophthalmic testing center systemcan be configured to generate various statistics based on the measuredreading speed data, which may be combined with data from the normativedatabase or historical data source.

With reference to FIG. 54, the OCT-based ophthalmic testing centersystem can be configured to output the results of and/or data from thereading speed test. For example, the results can be outputted directlyto the subject in a hardcopy (for example, printed card or paper) orelectronic format (for example, on a display, via email, text messaged,or in a magnetic strip), stored locally on the device or on an attachedcomputer, transmitted to a central database, or transmitted directly tothe ordering or related physician.

Stereoacuity Testing

With reference to FIG. 55 and FIG. 56, stereopsis is generally a measureof depth perception, and stereoacuity testing of the eyes can be used todetect a loss of stereopsis when viewing paired stereo images.Stereoacuity testing can be performed on children and adults. Levels ofstereopsis are measured in arc seconds, and can be detected bypresenting a subject with a sequence of sets of image pairs withprogressively increasing stereo disparity. Out of all of the imagespresented at each level of stereoacuity, the subject must choose thesingle image that looks three dimensional. If they answer correctly, theexaminer moves onto image sets with finer levels of disparity until thesubject no longer answers correctly or reaches the end of the test. Atthis point, the subject's level of stereoacuity, measured in arcseconds, is listed as the value associated with the last set ofstereoimages that the subject identified correctly.

In reference to FIG. 55 and FIG. 56, an OCT-based ophthalmic testingcenter system could accomplish stereoacuity testing in either aself-operated or self-administered fashion, or in an assisted fashionwhere someone other than the subject either partially or completelyadministers the test. The stereoacuity test is a functional test thatcan employ eye tracking methodologies, for example, tracking the foveausing foveal verification and/or foveal location. The stereoacuity testis also a binocular test where the two internal display devices presentstereo paired images or movies to a test subject. In variousembodiments, the OCT-based ophthalmic testing center system can usepolarized or colored targets. The OCT-based ophthalmic testing centersystem can be configured to control the optical distance between thesubject's eye and the fixation targets by adjusting the vergence of thelight from the fixation display (for example, by collimation ordivergence). For example, the optical distance could be set at 14 inchesto simulate reading, 30 inches to simulate computer use, 20 feet toequate with conventional visual acuity measurements, infinity, or at anyother distance. As discussed previously, the OCT-based ophthalmictesting center system can be configured to correct for refractive errorat the various optical distances.

In various embodiments, the OCT-based ophthalmic testing center systemcan be configured to instruct (visually and/or audibly) the subject toclick a button on the device or to verbally say ‘Yes’ whenever thesubject appreciates, sees, views, identifies, or perceives images instereo. The OCT-based ophthalmic testing center system can be configuredto process the subject's verbal responses by using speech recognitionsoftware within the device. After providing those instructions, theOCT-based ophthalmic testing center system device can be configured topresent images to the subject. The OCT-based ophthalmic testing centersystem can be configured to progressively increase the stereodisparitybetween paired images by shifting these images outwards, for examplealong the epipolar line that relates the two images, until the subjectpresses the button to indicate stereopsis or verbally says ‘Yes.’ Realworld images, movies or simple targets, such as circles or the like,could be used as stereo paired images.

With reference to FIG. 56, the OCT-based ophthalmic testing centersystem can be configured to instruct (visually and/or audibly) thesubject, via its speaker device, display, or other output device, toreview four concurrently displayed images 5602 (or other number ofimages) and focus or gaze or direct the eyes of the subject toward thesingle image out of the four (or other number of images) in each setthat appears in 3D 5604. The OCT-based ophthalmic testing center systemcan be configured to present sets of objects 5602, either line drawingsor real-world images or the like, where only one of the image pairswould have stereo disparity 5604. The subject's gaze or the direction ofthe subject's eyes can be monitored with non-OCT imaging modalities bytracking detectable structures within the eye, for example, the fovea orother features or sets of features with unique or identifiable patternsof intensity. Non-OCT imaging modalities include without limitationinfrared (IR) imaging or scanning laser ophthalmoscopy (SLO) imaging.The OCT-based ophthalmic testing center system can also be configured tomonitor the subject's gaze by tracking detectable structures within theeye using small 3D-OCT scans centered on the four images in each setthat could potentially be seen in stereo. Detectable structures caninclude without limitation the fovea, other depressions or protrusionswithin the eye, or unique or identifiable patterns or combinations ofprotrusions and/or depressions that signify the point of preferredfixation in the retina.

In reference to FIG. 56, the OCT-based ophthalmic testing center systemcan be configured to analyze and/or survey all four image locations tomeasure or detect or determine the subject's degree of uncertainty (asthey glance back and forth between potential options). For example, ifall four image locations were scanned several times per second forseveral seconds, the number of times the fovea (or other feature fortracking) appeared in each of those image locations could be counted. Ifthe fovea only appeared in a particular image location during thatsurvey, this could imply that the user had high confidence that this wasthe image displayed in 3D. If, on the other hand, the fovea appeared inmore than one image location on many foveal verification scans, thiscould indicate that the subject was unsure which one was the imagedisplayed in 3D and was shifting fixation back and forth between thechoices.

In reference to FIG. 55 and FIG. 56, a button input or a plurality ofbuttons could be used in addition or instead of verbal responses toenable the subject to indicate that the subject is looking at thesubject's final guess or choice, or that the subject could not see anyobjects in 3D. Measurements made with this test can include, but not belimited to, the arc seconds of disparity between the last image pair setanswered correctly. If processed in real-time, the OCT-based ophthalmictesting center system can be configured to use the stereoacuity testdata in conjunction with or to augment additional test stimuli presentedto the subject. For example, if the subject demonstrates uncertaintyabout which image is displayed in stereo with the largeststereodisparity value, the OCT-based ophthalmic testing center systemdevice could switch the image content, for example from a chair to adisc, to see if that is easier for the subject to see. If not, thedevice could present the subject with larger stereodisparity image pairsthan are typically used in standard testing or switch to the testdemonstrated in FIG. 55. In various embodiments, the OCT-basedophthalmic testing center system can be configured to compare thestereoacuity test data to a normative database to determine patterns ofdeviation and/or generate risk assessments and/or clinical reports. Invarious embodiments, the OCT-based ophthalmic testing center system canbe configured to analyze, compare, and/or add the stereoacuity test datato other data, such as the subject's ophthalmic history data that isstored on a subject's input card or retrieved from a historical databaseor other history-taking modules incorporated into the OCT-basedophthalmic testing center system. In various embodiments, the OCT-basedophthalmic testing center system can be configured to automaticallyconduct a stereoacuity test based on ophthalmic history. For example, ifthe subject complains of not being able to see depths, the OCT-basedophthalmic testing center system can be configured to record and/orstore such information so that the OCT-based ophthalmic testing centersystem can be configured to automatically perform a stereoacuity testbased on the recorded complaint. In another example, if the patient hasa family history of color depth-perception issues or the like, and suchinformation is stored within the subject's ophthalmic history database,the OCT-based ophthalmic testing center system can be configured toautomatically perform a stereoacuity test. The OCT-based ophthalmictesting center system can be configured to generate various statisticsbased on the measured stereoacuity data, which may be combined with datafrom the normative database or historical data source.

With reference to FIG. 55 and FIG. 56 the OCT-based ophthalmic testingcenter system can be configured to output the results of and/or datafrom the stereoacuity test. For example, the results can be outputteddirectly to the subject in a hardcopy (for example, printed card orpaper) or electronic format (for example, on a display, via email, textmessaged, or in a magnetic strip), stored locally on the device or on anattached computer, transmitted to a central database, or transmitteddirectly to the ordering or related physician.

Foveal Suppression Testing

Foveal suppression can occur in children having amblyopia and can alsoarise in other circumstances in adults. In instances where the eyes of aperson project two images to the brain having discrepancies and/orhaving varying focus, the brain may in some cases suppress the imagefrom one of the eyes, thereby reducing confusion for the brain due toconflicting images. This phenomenon is known as foveal suppression.

With reference to FIG. 57, the OCT-based ophthalmic testing centersystem can also be configured to conduct foveal suppression testing ineither a self-operated or self-administered fashion, or in an assistedfashion where someone other than the subject either partially orcompletely administers the test. The foveal suppression test is afunctional test that can employ eye tracking methodologies, for example,tracking the fovea using foveal verification and/or foveal location.This test can be a binocular test where the two internal display devicesof the OCT-based testing center system present two different test images5702 and 5704. In various embodiments, the OCT-based ophthalmic testingcenter system comprises two internal display devices that can beconfigured to present polarized or colored targets to conduct the test.The optical distance between the subject's eye and the fixation targetscould be controlled by adjusting the vergence of the light from thefixation display (for example, by collimation or divergence). Forexample, the optical distance could be set at 14 inches to simulatereading, 30 inches to simulate computer use, 20 feet to equate withconventional visual acuity measurements, infinity, or at any otherdistance. As discussed previously, the OCT-based ophthalmic testingcenter system can be configured to correct for refractive error at thevarious optical distances.

With reference to FIG. 57, in various embodiments, the OCT-basedophthalmic testing center system can be configured to instruct (visuallyand/or audibly) the subject to look at the center dot in all of the dotsdisplayed. The OCT-based ophthalmic testing center system can beconfigured to display a five-dot pattern (a first image 5702 showingthree dots left justified on the left and a second image 5704 showingthree dots right justified on the right with exactly one dotoverlapping). Although six dots are being presented to the user, peoplewithout foveal suppression will generally see a five-dot pattern becausetwo of the dots overlap and appear as one. People with fovealsuppression will generally see a three-dot pattern or some other numberof dots. Although a five-dot pattern is discussed here, other dotpatterns and/or other numbers of dots could be used as well. While thesubject is focusing on what the subject perceives as the center dot, theOCT-based ophthalmic testing center system can be configured to monitorand/or determine the subject's gaze to detect foveal suppression. Thesubject's gaze can be monitored with non-OCT imaging modalities bytracking detectable structures within the eye, for example, the fovea orother depressions or protrusions. Non-OCT imaging modalities includewithout limitation infrared (IR) imaging or scanning laserophthalmoscopy (SLO) imaging. The OCT-based ophthalmic testing centersystem can also be configured to monitor the subject's gaze by trackingdetectable structures within the eye using small 3D-OCT scans centeredon the three potential central dot areas. Detectable structures caninclude without limitation the fovea, other depressions or protrusionswithin the eye, or unique or identifiable patterns or combinations ofprotrusions and/or depressions that signify the point of preferredfixation in the retina.

In reference to FIG. 57, the OCT-based ophthalmic testing center systemcan be configured to track movement of, for example, the fovea; however,other retinal features can be used. Before commencing a fovealsuppression test, the OCT-based ophthalmic testing center system isconfigured to detect the location of the fovea in both eyes by using,for example, the foveal location and foveal verification methodologiesand techniques disclosed above. After detecting the fovea, the OCT-basedophthalmic testing center system can be configured to display thefive-dot pattern 5702, 5704 discussed above and instruct the subject tolook at the center dot. By verifying the location of the fovea as thesubject gazes at what the subject perceives as the center dot in thegroup of visualized dots, the OCT-based ophthalmic testing center systemcan detect the direction of the subject's gaze. Based on the directionof the subject's gaze, the OCT-based ophthalmic testing center systemcan be configured to detect foveal suppression. For example, a gazedirection that is left of center would indicate right fovealsuppression, and a gaze direction that is right of center would indicateleft foveal suppression. If the eyes exhibit a central gaze directionduring the foveal suppression test, then the OCT-based testing centersystem would generally detect no foveal suppression. In variousembodiments, all three dot locations could be surveyed rapidly tomeasure the subject's degree of uncertainty which may reflect partial orsubclinical foveal suppression. For example, if all three potentialmiddle dot locations were scanned several times per second for severalseconds, the number of times the fovea (or other feature for tracking)appeared in each of those dot locations could be counted. If the foveaonly appeared in one dot location during that survey, this could implythat the user had high confidence that this was the middle dot. If, onthe other hand, the fovea appeared in more than one dot location on manyfoveal verification scans, this could indicate that the subject wasunsure which one was the middle dot and was shifting fixation back andforth between these choices. Verbal inputs indicating the number of dotsvisualized could also be used in place of gaze detection.

With reference to FIG. 58, in various embodiments, the OCT-basedophthalmic testing center system can be configured to display twodifferent test images 5802 and 5804 on the two internal display devices.The OCT-based ophthalmic testing center system can be configured toinstruct (audibly and/or visually) the user to report the number of dotsvisualized while the instrument presented the dot patterns 5802, 5804.The subject's verbal response, such as 2, 3, 4, or 5, would be receivedby the OCT-based ophthalmic testing center system's microphone and wouldbe interpreted by speech recognition software. The OCT-based ophthalmictesting center system can be configured to verify the response, forexample, by outputting (visually and/or audibly) the detected verbalresponse and instructing the subject to confirm the correctness of theresponse by, for example, clicking a button. Based on the verbalresponse, the OCT-based ophthalmic testing center system can beconfigured to detect foveal suppression. For example, a response of twowould indicate left foveal suppression, a response of three wouldindicate right foveal suppression, a response of 4 would indicatebilaterally intact foveae and a response beyond those would beunreliable.

With reference to FIG. 58, in various embodiments, the OCT-basedophthalmic testing center system can be configured to compare the fovealsuppression test data to a normative database to determine patterns ofdeviation and/or to generate risk assessments and/or clinical reports.In various embodiments, the OCT-based ophthalmic testing center systemcan be configured to analyze, compare, and/or add the foveal suppressiontest data to other data, such as the subject's ophthalmic history datathat is stored on a subject's input card or retrieved from a historicaldatabase or other history-taking modules incorporated into the OCT-basedophthalmic testing center system. In various embodiments, the OCT-basedophthalmic testing center system can be configured to automaticallyconduct a foveal suppression test based on ophthalmic history. Forexample, if the subject complains of confusion and/or distortion, theOCT-based ophthalmic testing center system can be configured to recordand/or store such information so that the OCT-based ophthalmic testingcenter system can be configured to automatically perform a fovealsuppression test based on the recorded complaint. In another example, ifthe patient has a family history of foveal misalignment or the like, andsuch information is stored within the subject's ophthalmic historydatabase, the OCT-based ophthalmic testing center system can beconfigured to automatically perform a foveal suppression test. TheOCT-based ophthalmic testing center system can be configured to generatevarious statistics based on the measured central visual distortion data,which may be combined with data from the normative database orhistorical data source.

With reference to FIG. 58, the OCT-based ophthalmic testing centersystem can be configured to output the results of and/or data from thefoveal suppression test. For example, the results can be outputteddirectly to the subject in a hardcopy (for example, printed card orpaper) or electronic format (for example, on a display, via email, textmessaged, or in a magnetic strip), stored locally on the device or on anattached computer, transmitted to a central database, or transmitteddirectly to the ordering or related physician.

A wide variety of variations to the devices, systems, methods, etc.described herein are possible. For example, the optical layout of theOCT instrument may vary widely.

An alternative configuration, for example, is shown in FIG. 59. Thisembodiment includes a housing 5910 including a pair of eyepieces 5912having light-occluding, hygienic eyepiece covers 5914 that receive thesubject's eyes 5916. Within the housing 5910 is a light source 5918,which may comprise for example a swept light source that directs lightinto left and right hand portions 5920, 5922 of the system for left andright eyes 5916, respectively. Each of the left and right hand portions5920, 5922 includes an interferometer comprising a test arm 5924 thatextends into the eyepiece 5912 and through to the eye 5916 as well as areference arm 5926 and a light detection arm 5928. Each of the left andright hand portions 5920, 5922 also includes an arm 5930 having afixation target 5932 therein.

The test arm 5924 includes an ocular lens 5934 proximal to the eye 5916,auto-focus optics 5936 that is adjustable so as to selectively vary theshape of the beam directed into the eye 5916. The auto-focus optics 5936may include an auto-focus lens system comprising one or more lenses. Incertain embodiments, at least one lens is mounted to a translationstage, which may, for example, be longitudinally translatable, so as tovary the position of the lens and possibly the optical power of theauto-focus optics 5936 and/or the vergence of the light exiting theocular 5934. The auto-focus optics 5936 may additionally includevariable astigmatic correction optics that can be selectively adjustedto alter the astigmatism, and thus astigmatic correction, introducedinto the test arm. Stokes' lenses or other types of optical element(s)having variable astigmatism that can be selectively controlled, forexample, by altering the position or orientation of the astigmatismcorrection optics, may be used. In this manner, the magnitude and axisof cylinder may be adjusted so as to offset and/or correct astigmatismin the eye 5916 of the subject. As described above, adjustments to theauto-focus optics 5936 may permit a more focused beam to be directedinto the eye 5916 and may also be used to determine the refractive error(including, e.g., sphere, cylinder, and/or axis) of the subject.

The test arm 5924 additionally includes scanners 5938 a, 5938 b such asgalvanometers. These scanners 5938 a, 5938 b may comprise mirrors thatare moved in different (for example, orthogonal) directions to scan thebeam, for example, in x and y directions (with z being the longitudinaldirection along the optical axis of the eye 5916). The test arm 5924 mayfurther comprise one or more lenses 5940 that can alter the vergence oflight from the light source 5918 and/or the fixation target 5932 tosimulate variations in distance to the fixation target. For example, theone or more lenses 5940 can be configured to transmit collimated lightto simulate distance viewing conditions or can be configured to divergethe light to simulate near target viewing.

The reference arm 5926 can include a mirror/reflector 5942 (or othermechanism to modify the optical path length) that is translatable alongthe z-direction to provide a z-offset reference adjustment. Translationof this reflector 5942 adjusts the z-offset of the OCT system.

A detector 5944 is included in the light detection arm 5928. Thisdetector 5944 may comprise a single photodetector in some embodiments,for example, when a swept light source is used. In alternativeembodiments, a detector array, linear or 2-D, may be employed. Examplesinclude CCD and CMOS detector arrays.

The fixation target arm 5930 includes a lens 5946 and a display 5932′for displaying the fixation target 5932. The display 5932′ may comprisea FLCOS, LCD, or other display device. This display 5932′ may displaytext, graphics, images, movies, etc. for viewing by the subject whilethe exam is being performed.

In the embodiment shown in FIG. 59, the light source 5918, test andreference arms 5924, 5926, as well as light detection arm 5928 andfixation target arm 5930 are coupled to a common optical path 5948,although other arrangements and configurations are possible. A series ofbeam splitters are used to couple the different arms to the commonoptical path 5948. A test arm beam splitter 5950 couples the test arm5924 to the common optical path 5948 and thus to the light source 5918.A reference arm beam splitter 5952 also couples the reference arm 5926to the common optical path 5948 and to the light source 5918. A lightdetection arm beam splitter 5954 couples the light detection arm 5928 tothe common optical path 5948 and thus to the test and reference arms5924, 5926. Additionally, a fixation target arm beam splitter 5956couples the fixation target arm 5930 to the common optical path 5948 andto the test arm 5924 through which the eye 5916 of the subject views thefixation target 5932.

Accordingly, a light beam emitted by the light source 5918 is directedby the test arm beam splitter 5950 into the test arm 5924 wherein thebeam is scanned, e.g., in orthogonal x and y directions using thescanning galvanometers 5938 a, 5938 b. The beam passes through theauto-focus optics 5936 and the ocular 5934 into the subject's eye 5916.The light beam is reflected from the subject's eye 5916 and returnsalong the test arm 5924. The beam is coupled into the common opticalpath 5948 by the test arm beam splitter 5950.

Light from the light source 5918 is also is directed by the referencearm beam splitter 5952 into the reference arm 5926 wherein the beam isreflected from the mirror 5942 and returned to the common optical path5948 via the reference arm beam splitter 5952. The mirror 5942 isscanned, for example, in the z-direction, to produce an A-scan (forexample, using time-domain OCT) and/or to determine the depth into theeye 5916 that is probed/imaged by the OCT instrument.

The light returned from the test arm 5924 and the reference arm 5926combines and interferes. The light from the test arm 5924 and thereference arm 5926 are directed into the light detection arm 5928 by thelight detection arm beam splitter 5954. The interference can thus bemonitored by the detector 5944, which is electrically coupled to adigital signal processor 5958 in the embodiment shown in FIG. 59. A CPU5960 is also shown electrically connected to and in communication withthe digital signal processor 5958.

Light from the fixation target 5932′ is also coupled by the fixationtarget arm beam splitter 5956 into the common optical path 5948. Thislight is then coupled into the test arm 5924 via the test arm beamsplitter 5950 such that the subject can view the fixation target 5932.The lens 5946 disposed with respect to the fixation target 5932 may, insome embodiments, collimate the light.

The left and the right portions 5920, 5922 may include similar opticalcomponents in certain embodiments. In various embodiments, a beamsplitter 5962 is disposed with respect to the light source 5918 tocouple some of the light from the light source to the left portion 5920and to the subject's left eye 5916 and some of the light to the rightportion 5922 and to the subject's right eye. An interpupillaryadjustment control 5964 may be provided to adjust the interpupillarydistance of the eyepieces 5912.

The optical layout can vary from that shown in FIG. 59. The system canbe configured differently. For example, optical fiber (e.g.,microfibers) may be used to provide the optical paths with optical fibercouplers coupling paths together. Integrated optics may be used.Additionally, different optical and electrical components can beemployed. Additional components can be added or components can beremoved. The methods used to test the eye 5916 may vary as well.

All of the methods and processes described above may be embodied in, andfully automated via, software code modules executed by one or moregeneral purpose computers or processors. The code modules may be storedin any type of computer-readable medium or other computer storagedevice. Some or all of the methods may alternatively be embodied inspecialized computer hardware.

Conditional language, for example, among others, “can,” “could,”“might,” or “may,” unless specifically stated otherwise, or otherwiseunderstood within the context as used, is generally intended to conveythat certain embodiments include, while other embodiments do notinclude, certain features, elements and/or steps. Thus, such conditionallanguage is not generally intended to imply that features, elementsand/or steps are in any way required for one or more embodiments or thatone or more embodiments necessarily include logic for deciding, with orwithout user input or prompting, whether these features, elements and/orsteps are included or are to be performed in any particular embodiment.

While the invention has been discussed in terms of certain embodiments,it should be appreciated that the invention is not so limited. Theembodiments are explained herein by way of example, and there arenumerous modifications, variations and other embodiments that may beemployed that would still be within the scope of the present invention.Some embodiments have been described in connection with the accompanyingdrawings. However, it should be understood that the figures are notdrawn to scale. Distances, angles, etc. are merely illustrative and donot necessarily bear an exact relationship to actual dimensions andlayout of the devices illustrated. Components can be added, removed,and/or rearranged. Additionally, the skilled artisan will recognize thatany of the above-described methods can be carried out using anyappropriate apparatus. Further, the disclosure herein of any particularfeature, aspect, method, property, characteristic, quality, attribute,element, or the like in connection with various embodiments can be usedin all other embodiments set forth herein. Additionally, processingsteps may be added, removed, or reordered. A wide variety of designs andapproaches are possible.

For purposes of this disclosure, certain aspects, advantages, and novelfeatures of the invention are described herein. It is to be understoodthat not necessarily all such advantages may be achieved in accordancewith any particular embodiment of the invention. Thus, for example,those skilled in the art will recognize that the invention may beembodied or carried out in a manner that achieves one advantage or groupof advantages as taught herein without necessarily achieving otheradvantages as may be taught or suggested herein.

1. (canceled)
 2. An optical coherence tomography instrument comprising:an eyepiece; a target display visible through the eyepiece; a lightsource that outputs light that is directed through the eyepiece; abeamsplitter configured to combine light from two light paths; aninterferometer configured to produce optical interference using lightreflected from an eye of a user; an optical detector disposed so as todetect the optical interference; a processor configured to producefeatures on the target display of varying size to test the user's visualacuity.
 3. The optical coherence tomography instrument of claim 2,wherein the features are alphanumeric symbols.
 4. The optical coherencetomography instrument of claim 3, wherein the alphanumeric symbols varyin contrast and/or color.
 5. The optical coherence tomography instrumentof claim 2, wherein the processor is configured to output results of thevisual acuity test.
 6. The optical coherence tomography instrument ofclaim 2, wherein the processor is further configured to conduct a colorvision test.
 7. The optical coherence tomography instrument of claim 2,wherein the processor is further configured to conduct a visual fieldtest.
 8. The optical coherence tomography instrument of claim 2, whereinthe instrument is configured to obtain a first image of a region of theeye of the user at a first time period and a second image of the regionof the eye of the user at a second time period.
 9. The optical coherencetomography instrument of claim 8, wherein the processor is configured toperform tracking of at least one structural element of the eye betweenthe first and second images.
 10. The optical coherence tomographyinstrument of claim 9, wherein the processor is configured to perform atleast one ophthalmic functional test based on the tracking.
 11. Theoptical coherency tomography instrument of claim 2, wherein the beamsplitter is configured to combine light from the target display and thelight source.
 12. The optical coherence tomography instrument of claim2, wherein the beam splitter is configured to combine light from areference arm and a sample arm.
 13. An optical coherence tomographyinstrument comprising: an eyepiece; a target display visible through theeyepiece; a light source that outputs light that is directed through theeyepiece; an interferometer configured to produce optical interferenceusing light reflected from an eye of a user; an optical detectordisposed so as to detect the optical interference; a processorconfigured to produce features on the target display of varying size totest the user's visual acuity; and an adjustable optical elementconfigured to focus the features on the retina; wherein the opticalcoherence tomography instrument is configured to obtain an opticalcoherence tomography scan of a region of the eye.
 14. The opticalcoherence tomography instrument of claim 13, wherein the features arealphanumeric symbols.
 15. The optical coherence tomography instrument ofclaim 13, wherein the processor is configured to output results of thevisual acuity test.
 16. The optical coherence tomography instrument ofclaim 13, wherein the region of the eye is an anterior eye region. 17.The optical coherence tomography-based system of claim 16, wherein theoptical coherence tomography instrument is configured to obtain a secondoptical coherence tomography scan of the retina.
 18. The opticalcoherence tomography instrument of claim 17, wherein the anterior eyeregion comprises a cornea.
 19. The optical coherence tomography-basedsystem of claim 13, wherein the processor is further configured toconduct a corneal topography test based on the optical coherencetomography scan.
 20. The optical coherence tomography-based system ofclaim 13, wherein the processor is further configured to conduct acorneal pachymetry test based on the optical coherence tomography scan.21. The optical coherence tomography-based system of claim 13, theoptical coherence tomography device configured to enable the user toself-administer the optical coherence tomography scan.
 22. The opticalcoherence tomography-based system of claim 13, wherein the processor isfurther configured to conduct a pupillometry test based on the opticalcoherence tomography scan.
 23. The optical coherence tomography-basedsystem of claim 13, wherein the processor is further configured toconduct an extraocular motility test based on the optical coherencetomography scan.